GELFOAM
Report
- Report Number
- 1810189-2020-00047
- Event Type
- Injury
- Date Received
- May 13, 2020
- Report Date
- April 29, 2020
- Manufacturer
- PFIZER, INC. (DEVICE)
- Product Code
- LMF
- PMA / PMN Number
- 18-286
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
THE SEVERITY OF HARM WAS S3. PGS (SITE NAME) DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. THE SAMPLE AVAILABILITY STATUS WAS UNKNOWN. ROOT CAUSE: PFIZER (SITE NAME WITHHELD) QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE (SITE NAME WITHHELD) PRODUCTION PROCESS. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF A BATCH NUMBER, OR A ROOT CAUSE FOR THE REPORTED COMPLAINT. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER (SITE NAME WITHHELD). PROCESS CONTROL EVALUATION: EXISTING PROCESS CONTROLS WERE REVIEWED AS A PART OF THIS INVESTIGATION. THE REVIEW DETERMINED THAT THE PROCESS CONTROLS WERE APPROPRIATE AND ACCEPTABLE; THEREFORE THE MEDICAL DEVICE QOP WAS NOT NOTIFIED. LOT TREND ASSMT. & RATIONALE: BATCH SPECIFIC TREND REVIEW: COMPLETE - ACCEPTABLE. THE BATCH NUMBER FOR THE REPORTED COMPLAINT IS UNKNOWN; THEREFORE, AN EVALUATION OF THE BATCH HISTORY COULD NOT BE PERFORMED AS A PART OF THIS INVESTIGATION. MEDICAL DEVICE TREND ANALYSIS: COMPLETE - ACCEPTABLE. TIME PERIOD: 14MAY2017 -14MAY2020. THERE WAS ONE MONTH (JANUARY 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (24); HOWEVER, THIS WAS DUE TO THE REMEDIATION EFFORT BY PFIZER US SAFETY. ADDITIONALLY, THE RESULTS FROM THE QUERY WERE EVALUATED BY THE SUB-CLASS OF 'ADVERSE EVENT/SERIOUS/UNKNOWN', AND THERE WERE TWO MONTHS (JANUARY AND MARCH 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (12 AND 13, RESPECTIVELY); HOWEVER, THESE WERE ALSO DUE TO AN ON-GOING REMEDIATION EFFORT BY PFIZER US SAFETY. NO TREND WAS OBSERVED THAT WOULD REQUIRE FURTHER INVESTIGATION. INVESTIGATION FINDINGS: SUMMARY OF INVESTIGATION: PFIZER (SITE NAME WITHHELD) QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE (SITE NAME)PRODUCTION PROCESS. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF A BATCH NUMBER, OR A ROOT CAUSE FOR THE REPORTED COMPLAINT. ALL REVIEWED RECORDS, TRENDS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER (SITE NAME WITHELD). BASED UPON THE RESULTS OF THIS INVESTIGATION, (SITE NAME WITHHELD) CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. CONCLUSION: BASED ON THE COMPLAINT NARRATIVE, THE PATIENT EXPERIENCED A POSTOPERATIVE URINARY TRACT INFECTION AND WOUND INFECTION FOR GELFOAM ABSORBABLE GELATIN. THE REVIEW OF ALL RECORDS AND REPORTS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. REGULATORY REPORTABILITY WILL BE DETERMINED BY THE DCHU. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN SENT TO THE MDCP TEAM FOR REVIEW. FURTHER ACTION BY PFIZER (SITE NAME WITHHELD) IS NOT REQUIRED.
THE SEVERITY OF HARM WAS S3. PGS (SITE NAME) DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. THE SAMPLE AVAILABILITY STATUS WAS UNKNOWN. ROOT CAUSE: PFIZER (SITE NAME WITHHELD) QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE (SITE NAME WITHHELD) PRODUCTION PROCESS. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF A BATCH NUMBER, OR A ROOT CAUSE FOR THE REPORTED COMPLAINT. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER (SITE NAME WITHHELD). PROCESS CONTROL EVALUATION: EXISTING PROCESS CONTROLS WERE REVIEWED AS A PART OF THIS INVESTIGATION. THE REVIEW DETERMINED THAT THE PROCESS CONTROLS WERE APPROPRIATE AND ACCEPTABLE; THEREFORE THE MEDICAL DEVICE QOP WAS NOT NOTIFIED. LOT TREND ASSMT. & RATIONALE: BATCH SPECIFIC TREND REVIEW: COMPLETE - ACCEPTABLE. THE BATCH NUMBER FOR THE REPORTED COMPLAINT IS UNKNOWN; THEREFORE, AN EVALUATION OF THE BATCH HISTORY COULD NOT BE PERFORMED AS A PART OF THIS INVESTIGATION. MEDICAL DEVICE TREND ANALYSIS: COMPLETE - ACCEPTABLE. TIME PERIOD: 14MAY2017 -14MAY2020. THERE WAS ONE MONTH (JANUARY 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (24); HOWEVER, THIS WAS DUE TO THE REMEDIATION EFFORT BY PFIZER US SAFETY. ADDITIONALLY, THE RESULTS FROM THE QUERY WERE EVALUATED BY THE SUB-CLASS OF 'ADVERSE EVENT/SERIOUS/UNKNOWN', AND THERE WERE TWO MONTHS (JANUARY AND MARCH 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (12 AND 13, RESPECTIVELY); HOWEVER, THESE WERE ALSO DUE TO AN ON-GOING REMEDIATION EFFORT BY PFIZER US SAFETY. NO TREND WAS OBSERVED THAT WOULD REQUIRE FURTHER INVESTIGATION. INVESTIGATION FINDINGS: SUMMARY OF INVESTIGATION: PFIZER (SITE NAME WITHHELD) QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE (SITE NAME)PRODUCTION PROCESS. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF A BATCH NUMBER, OR A ROOT CAUSE FOR THE REPORTED COMPLAINT. ALL REVIEWED RECORDS, TRENDS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER (SITE NAME WITHELD). BASED UPON THE RESULTS OF THIS INVESTIGATION, (SITE NAME WITHHELD) CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. CONCLUSION: BASED ON THE COMPLAINT NARRATIVE, THE PATIENT EXPERIENCED A POSTOPERATIVE URINARY TRACT INFECTION AND WOUND INFECTION FOR GELFOAM ABSORBABLE GELATIN. THE REVIEW OF ALL RECORDS AND REPORTS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. REGULATORY REPORTABILITY WILL BE DETERMINED BY THE DCHU. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN SENT TO THE MDCP TEAM FOR REVIEW. FURTHER ACTION BY PFIZER (SITE NAME WITHHELD) IS NOT REQUIRED.
SEVERITY OF HARM WAS S4. FAILURE MODE WAS POST-OPERATIVE INFECTION. SUMMARY OF INVESTIGATION /CONCLUSION: THERE WERE NO CORRECTIONS PERFORMED, OR CORRECTIVE OR PREVENTATIVE ACTIONS IDENTIFIED, AS A RESULT OF THIS COMPLAINT INVESTIGATION. INVESTIGATION OF THE COMPLAINT DID NOT DETERMINE THE REPORTED ISSUE TO BE PROCESS RELATED; THEREFORE, A CORRECTION, OR CORRECTIVE OR PREVENTATIVE ACTION, IS NOT REQUIRED FOR THIS CASE. ADDITIONALLY, A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF CORRECTIONS, OR CORRECTIVE OR PREVENTATIVE ACTIONS FOR THE REPORTED COMPLAINT. ALL REVIEWED RECORDS, TRENDS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. THERE IS NO INDICATION THAT THE DEVICES FAILED TO MEET REGISTERED SPECIFICATIONS. BASED UPON THE RESULTS OF THIS INVESTIGATION, THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE.
EVENT VERBATIM [PREFERRED TERM]. SUPERFICIAL WOUND INFECTION [WOUND INFECTION], , NARRATIVE: EFFECTS OF INTRAOPERATIVE LOCAL STEROID UTILIZATION IN A SINGLE-LEVEL MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION. THIS IS A REPORT FROM A NON-PFIZER SPONSORED INTERVENTIONAL STUDY SOURCE, FOR STUDY ID: NCT03308084, FROM J NEUROSURG SPINE 2019; 30:222-227, ENTITLED " IMPACT OF LOCAL STEROID APPLICATION IN A MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION: RESULTS OF A PROSPECTIVE, RANDOMIZED, SINGLE-BLIND TRIAL ". THE AUTHOR REPORTED FOR 4 PATIENTS ON SAME PRODUCTS. THIS IS THE SECOND OF THE 4 REPORTS. A SUBJECT OF UNSPECIFIED AGE AND GENDER WHO WAS RANDOMIZED INTO DEPOMEDROL (DEPO) COHORTS STARTED TO RECEIVE METHYLPREDNISOLONE ACETATE (DEPO-MEDROL) 80MG, VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION AT 1 ML DEPOMEDROL (80 MG) APPLIED DIRECTLY TO THE SURGICAL SITE BY USING A GELFOAM CARRIER FOR AN UNSPECIFIED INDICATION, ABSORBABLE GELATIN (GELFOAM), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION BY USING A 10-CM2 GELFOAM CARRIER FOR AN UNSPECIFIED INDICATION. THE SUBJECT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE SUBJECT IN THE DEPO COHORT DEVELOPED SUPERFICIAL WOUND INFECTIONS IN THE FIRST 6 POSTOPERATIVE WEEKS THAT RESOLVED WITH ORAL ANTIBIOTIC THERAPY. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR METHYLPREDNISOLONE ACETATE AND ABSORBABLE GELATIN WAS UNKNOWN. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF SUPERFICIAL WOUND INFECTION WAS ORAL ANTIBIOTIC THERAPY. THE OUTCOME OF EVENT WAS RECOVERED. FOLLOW-UP (29JUN2020): THIS IS A FOLLOW-UP REPORT RECEIVED FROM PFIZER PRODUCT QUALITY COMPLAINT GROUP WITH INVESTIGATION RESULTS FOR GELFOAM. THE UDI WAS (B)(4) FOR ABSORBABLE GELATIN. SAMPLE STATUS WAS SAMPLE AVAILABILITY UNKNOWN. PHOTOS NOT AVAILABLE. SITE SAMPLE STATUS WAS NOT RECEIVED. SEVERITY OF HARM WAS S4. FAILURE MODE WAS POST-OPERATIVE INFECTION. SUMMARY OF INVESTIGATION /CONCLUSION: THERE WERE NO CORRECTIONS PERFORMED, OR CORRECTIVE OR PREVENTATIVE ACTIONS IDENTIFIED, AS A RESULT OF THIS COMPLAINT INVESTIGATION. INVESTIGATION OF THE COMPLAINT DID NOT DETERMINE THE REPORTED ISSUE TO BE PROCESS RELATED; THEREFORE, A CORRECTION, OR CORRECTIVE OR PREVENTATIVE ACTION, IS NOT REQUIRED FOR THIS CASE. ADDITIONALLY, A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF CORRECTIONS, OR CORRECTIVE OR PREVENTATIVE ACTIONS FOR THE REPORTED COMPLAINT. ALL REVIEWED RECORDS, TRENDS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. THERE IS NO INDICATION THAT THE DEVICES FAILED TO MEET REGISTERED SPECIFICATIONS. BASED UPON THE RESULTS OF THIS INVESTIGATION, THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. FOLLOW-UP (01JUL2020): NEW INFORMATION RECEIVED FROM PFIZER PRODUCT QUALITY COMPLAINT GROUP WITH INVESTIGATION RESULTS FOR GELFOAM INCLUDED: THE SEVERITY OF HARM WAS S3. PGS (SITE NAME) DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. THE SAMPLE AVAILABILITY STATUS WAS UNKNOWN. ROOT CAUSE: PFIZER (SITE NAME WITHHELD) QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE (SITE NAME WITHHELD) PRODUCTION PROCESS. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF A BATCH NUMBER, OR A ROOT CAUSE FOR THE REPORTED COMPLAINT. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER (SITE NAME WITHHELD). PROCESS CONTROL EVALUATION: EXISTING PROCESS CONTROLS WERE REVIEWED AS A PART OF THIS INVESTIGATION. THE REVIEW DETERMINED THAT THE PROCESS CONTROLS WERE APPROPRIATE AND ACCEPTABLE; THEREFORE THE MEDICAL DEVICE QOP WAS NOT NOTIFIED. LOT TREND ASSMT. & RATIONALE: BATCH SPECIFIC TREND REVIEW: COMPLETE - ACCEPTABLE. THE BATCH NUMBER FOR THE REPORTED COMPLAINT IS UNKNOWN; THEREFORE, AN EVALUATION OF THE BATCH HISTORY COULD NOT BE PERFORMED AS A PART OF THIS INVESTIGATION. MEDICAL DEVICE TREND ANALYSIS: COMPLETE - ACCEPTABLE. TIME PERIOD: 14MAY2017 -14MAY2020. THERE WAS ONE MONTH (JANUARY 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (24); HOWEVER, THIS WAS DUE TO THE REMEDIATION EFFORT BY PFIZER US SAFETY. ADDITIONALLY, THE RESULTS FROM THE QUERY WERE EVALUATED BY THE SUB-CLASS OF 'ADVERSE EVENT/SERIOUS/UNKNOWN', AND THERE WERE TWO MONTHS (JANUARY AND MARCH 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (12 AND 13, RESPECTIVELY); HOWEVER, THESE WERE ALSO DUE TO AN ON-GOING REMEDIATION EFFORT BY PFIZER US SAFETY. NO TREND WAS OBSERVED THAT WOULD REQUIRE FURTHER INVESTIGATION. INVESTIGATION FINDINGS: SUMMARY OF INVESTIGATION: PFIZER (SITE NAME WITHHELD) QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE (SITE NAME)PRODUCTION PROCESS. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF A BATCH NUMBER, OR A ROOT CAUSE FOR THE REPORTED COMPLAINT. ALL REVIEWED RECORDS, TRENDS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER (SITE NAME WITHELD). BASED UPON THE RESULTS OF THIS INVESTIGATION, (SITE NAME WITHHELD) CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. CONCLUSION: BASED ON THE COMPLAINT NARRATIVE, THE PATIENT EXPERIENCED A POSTOPERATIVE URINARY TRACT INFECTION AND WOUND INFECTION FOR GELFOAM ABSORBABLE GELATIN. THE REVIEW OF ALL RECORDS AND REPORTS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. REGULATORY REPORTABILITY WILL BE DETERMINED BY THE DCHU. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN SENT TO THE MDCP TEAM FOR REVIEW. FURTHER ACTION BY PFIZER (SITE NAME WITHHELD) IS NOT REQUIRED. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: TO EDIT NARRATIVE AND UPDATE REFERENCE FOR E2B LINK. COMPANY CLINICAL EVALUATION COMMENT: THE REPORTED EVENT OF WOUND INFECTION IS UNLISTED IN THE CDS OF THE PFIZER SUSPECT PRODUCTS METHYLPREDNISOLONE ACETATE AND WAS ASSESSED AS RELATED BY THE REPORTER AND COMPANY. ON THE OTHER HAND, THE SAID EVENT IS ALSO UNLISTED IN THE CDS OF THE PFIZER SUSPECT PRODUCT ABSORBABLE GELATIN WHICH WAS ASSESSED AS RELATED BY THE REPORTER BUT UNRELATED BY THE COMPANY. BASED ON TEMPORAL RELATIONSHIP AND LIMITED INFORMATION AVAILABLE, A POSSIBLE CONTRIBUTORY ROLE OF THE SUSPECT DRUGS METHYLPREDNISOLONE ACETATE, CANNOT BE EXCLUDED FOR THE REPORTED EVENT OF WOUND INFECTION. THE SAID EVENT IS CONSIDERED UNRELATED TO ABSORBABLE GELATIN AS THE EVENT LIKELY REPRESENT INTERCURRENT MEDICAL CONDITIONS IN REFERENCE TO ABSORBABLE GELATIN. THIS CASE WILL BE REASSESSED WHEN ADDITIONAL INFORMATION IS RECEIVED. THE IMPACT OF THIS REPORT ON THE BENEFIT-RISK PROFILE OF THE PFIZER PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR AE. ANY SAFETY CONCERN IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTION IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED., COMMENT: THE REPORTED EVENT OF WOUND INFECTION IS UNLISTED IN THE CDS OF THE PFIZER SUSPECT PRODUCTS METHYLPREDNISOLONE ACETATE AND WAS ASSESSED AS RELATED BY THE REPORTER AND COMPANY. ON THE OTHER HAND, THE SAID EVENT IS ALSO UNLISTED IN THE CDS OF THE PFIZER SUSPECT PRODUCT ABSORBABLE GELATIN WHICH WAS ASSESSED AS RELATED BY THE REPORTER BUT UNRELATED BY THE COMPANY BASED ON TEMPORAL RELATIONSHIP AND LIMITED INFORMATION AVAILABLE, A POSSIBLE CONTRIBUTORY ROLE OF THE SUSPECT DRUGS METHYLPREDNISOLONE ACETATE, CANNOT BE EXCLUDED FOR THE REPORTED EVENT OF WOUND INFECTION. THE SAID EVENT IS CONSIDERED UNRELATED TO ABSORBABLE GELATIN AS THE EVENT LIKELY REPRESENT INTERCURRENT MEDICAL CONDITIONS IN REFERENCE TO ABSORBABLE GELATIN. THIS CASE WILL BE REASSESSED WHEN ADDITIONAL INFORMATION IS RECEIVED. THE IMPACT OF THIS REPORT ON THE BENEFIT-RISK PROFILE OF THE PFIZER PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR AE. ANY SAFETY CONCERN IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTION IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE.
EVENT VERBATIM [PREFERRED TERM], SUPERFICIAL WOUND INFECTION [WOUND INFECTION], NARRATIVE: EFFECTS OF INTRAOPERATIVE LOCAL STEROID UTILIZATION IN A SINGLE-LEVEL MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION THIS IS A NON-PFIZER SPONSORED INTERVENTIONAL STUDY, STUDY ID: (B)(4), FROM J NEUROSURG SPINE 2019; 30:222-227, ENTITLED " IMPACT OF LOCAL STEROID APPLICATION IN A MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION: RESULTS OF A PROSPECTIVE, RANDOMIZED, SINGLE-BLIND TRIAL ". A SUBJECT OF UNSPECIFIED AGE AND GENDER WHO WAS RANDOMIZED INTO DEPOMEDROL (DEPO) COHORTS STARTED TO RECEIVE METHYLPREDNISOLONE ACETATE (DEPO-MEDROL) 80MG, VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION AT 1 ML DEPOMEDROL (80 MG) APPLIED DIRECTLY TO THE SURGICAL SITE BY USING A GELFOAM CARRIER FOR AN UNSPECIFIED INDICATION, ABSORBABLE GELATIN (GELFOAM), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION BY USING A 10-CM2 GELFOAM CARRIER FOR AN UNSPECIFIED INDICATION. THE SUBJECT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE SUBJECT IN THE DEPO COHORT DEVELOPED SUPERFICIAL WOUND INFECTIONS IN THE FIRST 6 POSTOPERATIVE WEEKS THAT RESOLVED WITH ORAL ANTIBIOTIC THERAPY. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR METHYLPREDNISOLONE ACETATE WAS UNKNOWN, FOR ABSORBABLE GELATIN WAS UNKNOWN. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF SUPERFICIAL WOUND INFECTION WAS ORAL ANTIBIOTIC THERAPY. THE OUTCOME OF EVENT WAS RECOVERED. OBJECTIVE: LOCAL EPIDURAL STEROID APPLICATION MAY BE ASSOCIATED WITH DECREASED PAIN AND NARCOTIC USE IN THE IMMEDIATE POSTOPERATIVE PERIOD FOLLOWING LUMBAR DISCECTOMY. HOWEVER, LOCAL STEROID DELIVERY FOLLOWING LUMBAR FUSION PROCEDURES HAS NOT BEEN WELL CHARACTERIZED. THIS STUDY AIMS TO CHARACTERIZE THE EFFECT OF LOCAL INTRAOPERATIVE DEPOMEDROL APPLICATION ON PERIOPERATIVE AND POSTOPERATIVE OUTCOMES FOLLOWING A SINGLE-LEVEL MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (MIS TLIF). METHODS: A PROSPECTIVE, RANDOMIZED, SINGLE-BLINDED STUDY WAS PERFORMED. A PRIORI POWER ANALYSIS DETERMINED THAT 86 PATIENTS WERE NEEDED TO DETECT A DIFFERENCE OF 1 POINT IN THE VISUAL ANALOG SCALE (VAS) PAIN SCORE BETWEEN GROUPS. NINETY-THREE PATIENTS WERE RANDOMIZED INTO DEPOMEDROL (DEPO) AND NO DEPOMEDROL (NODEPO) COHORTS. PRIOR TO SURGICAL CLOSURE, DEPO PATIENTS RECEIVED 1 ML DEPOMEDROL (80 MG) APPLIED DIRECTLY TO THE SURGICAL SITE BY USING A GELFOAM CARRIER. NODEPO PATIENTS RECEIVED 1 ML SALINE ON THE SAME GELFOAM CARRIER. PERIOPERATIVE OUTCOMES INCLUDING ACUTE POSTOPERATIVE PAIN AND NARCOTIC USE WERE ASSESSED FOR THE DURATION OF INPATIENT STAY. PATIENT-REPORTED OUTCOMES (PROS) QUESTIONNAIRES INCLUDING VAS BACK AND LEG PAIN SCORES, AND OSWESTRY DISABILITY INDEX (ODI) WERE ADMINISTERED PREOPERATIVELY AND AT 6-WEEK, 12-WEEK, AND 6-MONTH FOLLOW-UP. OUTCOMES FOR DEPO AND NODEPO COHORTS WERE COMPARED USING LINEAR REGRESSION CONTROLLED FOR SEX. RESULTS: A TOTAL OF 105 PATIENTS WERE ENROLLED AND RANDOMIZED TO THE DEPO (N = 52) OR NODEPO COHORTS (N = 53). FOUR PATIENTS IN THE DEPO COHORT INADVERTENTLY RECEIVED ONLY A 40-MG INJECTION OF DEPOMEDROL, AND THEREFORE WERE EXCLUDED FROM ANALYSIS. AN ADDITIONAL 8 PATIENTS WERE EXCLUDED FROM FINAL ANALYSIS DUE TO INCOMPLETE POSTOPERATIVE SURVEY COMPLETION (3 IN DEPO, 5 IN NODEPO). THEREFORE, 93 PATIENTS WERE INCLUDED IN THE FINAL ANALYSIS, OF WHICH 45 (48.4%) AND 48 (51.6%) WERE IN DEPO AND NODEPO GROUPS, RESPECTIVELY. A GREATER PERCENTAGE OF DEPO PATIENTS WERE FEMALE (53.3% VS 27.1%, P = 0.010). NO SIGNIFICANT DIFFERENCES IN PREOPERATIVE CHARACTERISTICS WERE IDENTIFIED BETWEEN GROUPS (P > 0.05). PERIOPERATIVE CHARACTERISTICS AND COMPLICATION RATES ARE DESCRIBED IN TABLE 2. PATIENTS IN THE DEPO AND NODEPO COHORT EXHIBITED SIMILAR OPERATING TIMES AND INTRAOPERATIVE BLOOD LOSS. THE LOS AND POSTOPERATIVE DAY OF DISCHARGE WERE ALSO FOUND TO BE SIMILAR BETWEEN GROUPS. ONE PATIENT IN THE DEPO COHORT EXPERIENCED POSTOPERATIVE URINARY RETENTION, REQUIRING A URINARY CATHETER UPON DISCHARGE AND FOLLOW-UP WITH UROLOGY. IN ADDITION, 2 PATIENTS IN THE DEPO GROUP DEVELOPED SUPERFICIAL WOUND INFECTIONS IN THE FIRST 6 POSTOPERATIVE WEEKS THAT RESOLVED WITH ORAL ANTIBIOTIC THERAPY. LAST, 1 PATIENT IN THE DEPO COHORT DEVELOPED SYMPTOMATIC PSEUDARTHROSIS, WHICH REQUIRED AN ANTERIOR LUMBAR INTERBODY FUSION AT THE INDEX LEVEL APPROXIMATELY 18 MONTHS POSTOPERATIVELY. NO COMPLICATIONS WERE OBSERVED IN THE NODEPO COHORT. STATISTICALLY SIGNIFICANT DIFFERENCES BETWEEN GROUPS FOR COMPLICATION RATES WERE NOT IDENTIFIED (P > 0.05 FOR EACH). INPATIENT PAIN SCORES AND NARCOTICS CONSUMPTION ARE DESCRIBED IN TABLE 3. NO DIFFERENCES IN ACUTE POSTOPERA- OBSERVED BETWEEN DEPO AND NODEPO GROUPS (P > 0.05). PATIENTS IN THE DEPO COHORT CONSUMED FEWER HOURLY NARCOTICS ON POD 0 (5.3 VS 6.3 OMES/HOUR, P = 0.034). HOWEVER, THERE WERE NO DIFFERENCES BETWEEN GROUPS IN HOURLY NARCOTICS CONSUMPTION ON POD 1 OR 2 (P > 0.05). POSTOPERATIVE PRO IMPROVEMENTS FROM PREOPERATIVE SCORES ARE REPORTED IN TABLE 4. PREOPERATIVE VAS LEG SCORES WERE STATISTICALLY DIFFERENT BETWEEN COHORTS (P = 0.027). HOWEVER, PREOPERATIVE ODI AND VAS BACK SCORES DID NOT DIFFER BETWEEN GROUPS (P > 0.05). ADDITIONALLY, DEPO AND NODEPO GROUPS EXPERIENCED SIMILAR IMPROVEMENTS IN PROS AT ALL POSTOPERATIVE TIME POINTS. FURTHERMORE, PATIENTS IN BOTH COHORTS ACHIEVED MCID FOR ODI, VAS BACK, AND VAS LEG AT SIMILAR RATES (P > 0.05). DISCUSSION: COMPLICATIONS RELATED TO THE ADMINISTRATION OF LOCAL INTRAOPERATIVE STEROIDS REMAIN A CONSIDERATION WITH ITS ROUTINE USE. IN THE PRESENT STUDY A GREATER NUMBER OF COMPLICATIONS OCCURRED IN THE DEPO COHORT. THESE COMPLICATIONS INCLUDED 1 PATIENT WITH POSTOPERATIVE URINARY RETENTION, 2 PATIENTS WITH SUPERFICIAL WOUND INFECTIONS, AND 1 PATIENT REQUIRING A REPEAT OPERATION FOR SYMPTOMATIC PSEUDARTHROSIS. HOWEVER, THIS WAS NOT A STATISTICALLY SIGNIFICANT ASSOCIATION. THE AFOREMENTIONED STUDY BY AKINDURO ET AL. ALSO INVESTIGATED COMPLICATION RATES WITH INTRAOPERATIVE STEROID USE.1 IN A META-ANALYSIS, THE AUTHORS IDENTIFIED A TREND TOWARD HIGHER INFECTIOUS (0.94% VS 0.08%, P = 0.10) AND TOTAL COMPLICATION RATE (2.69% VS 1.18%, P = 0.19) AMONG THOSE RECEIVING INTRAOPERATIVE STEROIDS, ALTHOUGH THESE WERE NOT STATISTICALLY SIGNIFICANT. IT WAS SUGGESTED THAT THIS COULD BE DUE TO A LOW OVERALL COMPLICATION RATE ASSOCIATED WITH LUMBAR DISCECTOMY THAT PREVENTED STATISTICALLY SIGNIFICANT DIFFERENCES. THESE RESULTS, IN COMBINATION WITH THOSE OF THE PRESENT STUDY, INDICATE THE NEED FOR FURTHER INVESTIGATION TO BETTER CHARACTERIZE THE RELATIONSHIP BETWEEN INTRAOPERATIVE STEROID USE AND COMPLICATION RATES FOR MIS TLIF. NEVERTHELESS, BECAUSE THE CURRENT LITERATURE IS INCONCLUSIVE, IT WOULD BE PRUDENT FOR SURGEONS TO ASSESS THE POTENTIAL RISK FOR COMPLICATIONS WHEN CONSIDERING THE USE OF LOCAL INTRAOPERATIVE STEROIDS FOR MIS TLIF. CONCLUSIONS: LOCAL DEPOMEDROL APPLICATION DID NOT LEAD TO DECREASES IN ACUTE POSTOPERATIVE PAIN OR NARCOTICS CONSUMPTION AFTER MIS TLIF. ADDITIONALLY, LOCAL DEPOMEDROL ADMINISTRATION WAS NOT ASSOCIATED WITH POSTOPERATIVE IMPROVEMENTS IN PROS. FINALLY, ALTHOUGH THE USE OF DEPOMEDROL WAS ASSOCIATED WITH SMALL INCREASES IN COMPLICATION RATES, THIS WAS NOT STATISTICALLY SIGNIFICANT. THE FINDINGS OF THIS RANDOMIZED TRIAL SUGGEST THAT THE USE OF LOCAL INTRAOPERATIVE STEROIDS MAY NOT PROVIDE ADDITIONAL BENEFIT WITH REGARD TO SURGICAL AND CLINICAL OUTCOMES IN PATIENTS WHO UNDERGO MIS TLIF. HOWEVER, ADDITIONAL STUDIES ARE NEEDED TO FURTHER ASSESS LONG-TERM OUTCOMES AND COMPLICATION RISKS WITH THE USE OF LOCAL INTRAOPERATIVE STEROIDS IN LUMBAR FUSION PROCEDURES. FOLLOW-UP (29JUN2020): THIS IS A REPORT FROM A NON-PFIZER SPONSORED INTERVENTIONAL STUDY SOURCE FOR PROTOCOL (B)(4). NEW INFORMATION INCLUDED: THE UDI WAS (B)(4) FOR ABSORBABLE GELATIN. SAMPLE STATUS WAS SAMPLE AVAILABILITY UNKNOWN. PHOTOS NOT AVAILABLE. SITE SAMPLE STATUS WAS NOT RECEIVED. SEVERITY OF HARM WAS S4. FAILURE MODE WAS POST-OPERATIVE INFECTION. SUMMARY OF INVESTIGATION /CONCLUSION: THERE WERE NO CORRECTIONS PERFORMED, OR CORRECTIVE OR PREVENTATIVE ACTIONS IDENTIFIED, AS A RESULT OF THIS COMPLAINT INVESTIGATION. INVESTIGATION OF THE COMPLAINT DID NOT DETERMINE THE REPORTED ISSUE TO BE PROCESS RELATED; THEREFORE, A CORRECTION, OR CORRECTIVE OR PREVENTATIVE ACTION, IS NOT REQUIRED FOR THIS CASE. ADDITIONALLY, A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF CORRECTIONS, OR CORRECTIVE OR PREVENTATIVE ACTIONS FOR THE REPORTED COMPLAINT. ALL REVIEWED RECORDS, TRENDS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. THERE IS NO INDICATION THAT THE DEVICES FAILED TO MEET REGISTERED SPECIFICATIONS. BASED UPON THE RESULTS OF THIS INVESTIGATION, THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. FOLLOW-UP (01JUL2020): THIS IS A FOLLOW-UP REPORT FROM A NON-PFIZER SPONSORED INTERVENTIONAL STUDY SOURCE FOR PROTOCOL (B)(4) RECEIVED FROM A PRODUCT QUALITY COMPLAINTS GROUP WITH INVESTIGATION RESULTS FOR GELFOAM STERILE SPONGE SIZE 50 X 4. THE SEVERITY OF HARM WAS S3. PGS (SITE NAME) DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. THE SAMPLE AVAILABILITY STATUS WAS UNKNOWN. ROOT CAUSE: PFIZER (SITE NAME WITHHELD) QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE (SITE NAME WITHHELD) PRODUCTION PROCESS. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF A BATCH NUMBER, OR A ROOT CAUSE FOR THE REPORTED COMPLAINT. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER (SITE NAME WITHHELD). PROCESS CONTROL EVALUATION: EXISTING PROCESS CONTROLS WERE REVIEWED AS A PART OF THIS INVESTIGATION. THE REVIEW DETERMINED THAT THE PROCESS CONTROLS WERE APPROPRIATE AND ACCEPTABLE; THEREFORE THE MEDICAL DEVICE QOP WAS NOT NOTIFIED. LOT TREND ASSMT. & RATIONALE: BATCH SPECIFIC TREND REVIEW: COMPLETE - ACCEPTABLE. THE BATCH NUMBER FOR THE REPORTED COMPLAINT IS UNKNOWN; THEREFORE, AN EVALUATION OF THE BATCH HISTORY COULD NOT BE PERFORMED AS A PART OF THIS INVESTIGATION. MEDICAL DEVICE TREND ANALYSIS: COMPLETE - ACCEPTABLE. TIME PERIOD: (B)(6) 2017 -(B)(6) 2020. THERE WAS ONE MONTH ((B)(6) 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (24); HOWEVER, THIS WAS DUE TO THE REMEDIATION EFFORT BY PFIZER US SAFETY. ADDITIONALLY, THE RESULTS FROM THE QUERY WERE EVALUATED BY THE SUB-CLASS OF 'ADVERSE EVENT/SERIOUS/UNKNOWN', AND THERE WERE TWO MONTHS ((B)(6) 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (12 AND 13, RESPECTIVELY); HOWEVER, THESE WERE ALSO DUE TO AN ON-GOING REMEDIATION EFFORT BY PFIZER US SAFETY. NO TREND WAS OBSERVED THAT WOULD REQUIRE FURTHER INVESTIGATION. INVESTIGATION FINDINGS: SUMMARY OF INVESTIGATION: PFIZER (SITE NAME WITHHELD) QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE (SITE NAME)PRODUCTION PROCESS. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF A BATCH NUMBER, OR A ROOT CAUSE FOR THE REPORTED COMPLAINT. ALL REVIEWED RECORDS, TRENDS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER (SITE NAME WITHELD). BASED UPON THE RESULTS OF THIS INVESTIGATION, (SITE NAME WITHHELD) CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. CONCLUSION: BASED ON THE COMPLAINT NARRATIVE, THE PATIENT EXPERIENCED A POSTOPERATIVE URINARY TRACT INFECTION AND WOUND INFECTION FOR GELFOAM ABSORBABLE GELATIN. THE REVIEW OF ALL RECORDS AND REPORTS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. REGULATORY REPORTABILITY WILL BE DETERMINED BY THE DCHU. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN SENT TO THE MDCP TEAM FOR REVIEW. FURTHER ACTION BY PFIZER (SITE NAME WITHHELD) IS NOT REQUIRED. COMPANY CLINICAL EVALUATION COMMENT: THE REPORTED EVENT OF WOUND INFECTION IS UNLISTED IN THE CDS OF THE PFIZER SUSPECT PRODUCTS METHYLPREDNISOLONE ACETATE AND WAS ASSESSED AS RELATED BY THE REPORTER AND COMPANY. ON THE OTHER HAND, THE SAID EVENT IS ALSO UNLISTED IN THE CDS OF THE PFIZER SUSPECT PRODUCT ABSORBABLE GELATIN WHICH WAS ASSESSED AS RELATED BY THE REPORTER BUT UNRELATED BY THE COMPANY. BASED ON TEMPORAL RELATIONSHIP AND LIMITED INFORMATION AVAILABLE, A POSSIBLE CONTRIBUTORY ROLE OF THE SUSPECT DRUGS METHYLPREDNISOLONE ACETATE, CANNOT BE EXCLUDED FOR THE REPORTED EVENT OF WOUND INFECTION. THE SAID EVENT IS CONSIDERED UNRELATED TO ABSORBABLE GELATIN AS THE EVENT LIKELY REPRESENT INTERCURRENT MEDICAL CONDITIONS IN REFERENCE TO ABSORBABLE GELATIN. THIS CASE WILL BE REASSESSED WHEN ADDITIONAL INFORMATION IS RECEIVED.THE IMPACT OF THIS REPORT ON THE BENEFIT-RISK PROFILE OF THE PFIZER PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR AE. ANY SAFETY CONCERN IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTION IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED., COMMENT: THE REPORTED EVENT OF WOUND INFECTION IS UNLISTED IN THE CDS OF THE PFIZER SUSPECT PRODUCTS METHYLPREDNISOLONE ACETATE AND WAS ASSESSED AS RELATED BY THE REPORTER AND COMPANY. ON THE OTHER HAND, THE SAID EVENT IS ALSO UNLISTED IN THE CDS OF THE PFIZER SUSPECT PRODUCT ABSORBABLE GELATIN WHICH WAS ASSESSED AS RELATED BY THE REPORTER BUT UNRELATED BY THE COMPANY BASED ON TEMPORAL RELATIONSHIP AND LIMITED INFORMATION AVAILABLE, A POSSIBLE CONTRIBUTORY ROLE OF THE SUSPECT DRUGS METHYLPREDNISOLONE ACETATE, CANNOT BE EXCLUDED FOR THE REPORTED EVENT OF WOUND INFECTION. THE SAID EVENT IS CONSIDERED UNRELATED TO ABSORBABLE GELATIN AS THE EVENT LIKELY REPRESENT INTERCURRENT MEDICAL CONDITIONS IN REFERENCE TO ABSORBABLE GELATIN. THIS CASE WILL BE REASSESSED WHEN ADDITIONAL INFORMATION IS RECEIVED. THE IMPACT OF THIS REPORT ON THE BENEFIT-RISK PROFILE OF THE PFIZER PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR AE. ANY SAFETY CONCERN IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTION IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE.
SUPERFICIAL WOUND INFECTION [WOUND INFECTION]. NARRATIVE: EFFECTS OF INTRAOPERATIVE LOCAL STEROID UTILIZATION IN A SINGLE-LEVEL MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION THIS IS A NON-PFIZER SPONSORED INTERVENTIONAL STUDY, STUDY ID: NCT03308084, FROM J NEUROSURG SPINE 2019; 30:222-227, ENTITLED " IMPACT OF LOCAL STEROID APPLICATION IN A MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION: RESULTS OF A PROSPECTIVE, RANDOMIZED, SINGLE-BLIND TRIAL ". A SUBJECT OF UNSPECIFIED AGE AND GENDER WHO WAS RANDOMIZED INTO DEPOMEDROL (DEPO) COHORTS STARTED TO RECEIVE METHYLPREDNISOLONE ACETATE (DEPO-MEDROL) 80MG, VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION AT 1 ML DEPOMEDROL (80 MG) APPLIED DIRECTLY TO THE SURGICAL SITE BY USING A GELFOAM CARRIER FOR AN UNSPECIFIED INDICATION, ABSORBABLE GELATIN (GELFOAM), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION BY USING A 10-CM2 GELFOAM CARRIER FOR AN UNSPECIFIED INDICATION. THE SUBJECT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE SUBJECT IN THE DEPO COHORT DEVELOPED SUPERFICIAL WOUND INFECTIONS IN THE FIRST 6 POSTOPERATIVE WEEKS THAT RESOLVED WITH ORAL ANTIBIOTIC THERAPY. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR METHYLPREDNISOLONE ACETATE WAS UNKNOWN, FOR ABSORBABLE GELATIN WAS UNKNOWN. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF SUPERFICIAL WOUND INFECTION WAS ORAL ANTIBIOTIC THERAPY. THE OUTCOME OF EVENT WAS RECOVERED. OBJECTIVE: LOCAL EPIDURAL STEROID APPLICATION MAY BE ASSOCIATED WITH DECREASED PAIN AND NARCOTIC USE IN THE IMMEDIATE POSTOPERATIVE PERIOD FOLLOWING LUMBAR DISCECTOMY. HOWEVER, LOCAL STEROID DELIVERY FOLLOWING LUMBAR FUSION PROCEDURES HAS NOT BEEN WELL CHARACTERIZED. THIS STUDY AIMS TO CHARACTERIZE THE EFFECT OF LOCAL INTRAOPERATIVE DEPOMEDROL APPLICATION ON PERIOPERATIVE AND POSTOPERATIVE OUTCOMES FOLLOWING A SINGLE-LEVEL MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (MIS TLIF). METHODS: A PROSPECTIVE, RANDOMIZED, SINGLE-BLINDED STUDY WAS PERFORMED. A PRIORI POWER ANALYSIS DETERMINED THAT 86 PATIENTS WERE NEEDED TO DETECT A DIFFERENCE OF 1 POINT IN THE VISUAL ANALOG SCALE (VAS) PAIN SCORE BETWEEN GROUPS. NINETY-THREE PATIENTS WERE RANDOMIZED INTO DEPOMEDROL (DEPO) AND NO DEPOMEDROL (NODEPO) COHORTS. PRIOR TO SURGICAL CLOSURE, DEPO PATIENTS RECEIVED 1 ML DEPOMEDROL (80 MG) APPLIED DIRECTLY TO THE SURGICAL SITE BY USING A GELFOAM CARRIER. NODEPO PATIENTS RECEIVED 1 ML SALINE ON THE SAME GELFOAM CARRIER. PERIOPERATIVE OUTCOMES INCLUDING ACUTE POSTOPERATIVE PAIN AND NARCOTIC USE WERE ASSESSED FOR THE DURATION OF INPATIENT STAY. PATIENT-REPORTED OUTCOMES (PROS) QUESTIONNAIRES INCLUDING VAS BACK AND LEG PAIN SCORES, AND OSWESTRY DISABILITY INDEX (ODI) WERE ADMINISTERED PREOPERATIVELY AND AT 6-WEEK, 12-WEEK, AND 6-MONTH FOLLOW-UP. OUTCOMES FOR DEPO AND NODEPO COHORTS WERE COMPARED USING LINEAR REGRESSION CONTROLLED FOR SEX. RESULTS: A TOTAL OF 105 PATIENTS WERE ENROLLED AND RANDOMIZED TO THE DEPO (N = 52) OR NODEPO COHORTS (N = 53). FOUR PATIENTS IN THE DEPO COHORT INADVERTENTLY RECEIVED ONLY A 40-MG INJECTION OF DEPOMEDROL, AND THEREFORE WERE EXCLUDED FROM ANALYSIS. AN ADDITIONAL 8 PATIENTS WERE EXCLUDED FROM FINAL ANALYSIS DUE TO INCOMPLETE POSTOPERATIVE SURVEY COMPLETION (3 IN DEPO, 5 IN NODEPO). THEREFORE, 93 PATIENTS WERE INCLUDED IN THE FINAL ANALYSIS, OF WHICH 45 (48.4%) AND 48 (51.6%) WERE IN DEPO AND NODEPO GROUPS, RESPECTIVELY. A GREATER PERCENTAGE OF DEPO PATIENTS WERE FEMALE (53.3% VS 27.1%, P = 0.010). NO SIGNIFICANT DIFFERENCES IN PREOPERATIVE CHARACTERISTICS WERE IDENTIFIED BETWEEN GROUPS (P > 0.05). PERIOPERATIVE CHARACTERISTICS AND COMPLICATION RATES ARE DESCRIBED IN TABLE 2. PATIENTS IN THE DEPO AND NODEPO COHORT EXHIBITED SIMILAR OPERATING TIMES AND INTRAOPERATIVE BLOOD LOSS. THE LOS AND POSTOPERATIVE DAY OF DISCHARGE WERE ALSO FOUND TO BE SIMILAR BETWEEN GROUPS. ONE PATIENT IN THE DEPO COHORT EXPERIENCED POSTOPERATIVE URINARY RETENTION, REQUIRING A URINARY CATHETER UPON DISCHARGE AND FOLLOW-UP WITH UROLOGY. IN ADDITION, 2 PATIENTS IN THE DEPO GROUP DEVELOPED SUPERFICIAL WOUND INFECTIONS IN THE FIRST 6 POSTOPERATIVE WEEKS THAT RESOLVED WITH ORAL ANTIBIOTIC THERAPY. LAST, 1 PATIENT IN THE DEPO COHORT DEVELOPED SYMPTOMATIC PSEUDARTHROSIS, WHICH REQUIRED AN ANTERIOR LUMBAR INTERBODY FUSION AT THE INDEX LEVEL APPROXIMATELY 18 MONTHS POSTOPERATIVELY. NO COMPLICATIONS WERE OBSERVED IN THE NODEPO COHORT. STATISTICALLY SIGNIFICANT DIFFERENCES BETWEEN GROUPS FOR COMPLICATION RATES WERE NOT IDENTIFIED (P > 0.05 FOR EACH). INPATIENT PAIN SCORES AND NARCOTICS CONSUMPTION ARE DESCRIBED IN TABLE 3. NO DIFFERENCES IN ACUTE POSTOPERA- OBSERVED BETWEEN DEPO AND NODEPO GROUPS (P > 0.05). PATIENTS IN THE DEPO COHORT CONSUMED FEWER HOURLY NARCOTICS ON POD 0 (5.3 VS 6.3 OMES/HOUR, P = 0.034). HOWEVER, THERE WERE NO DIFFERENCES BETWEEN GROUPS IN HOURLY NARCOTICS CONSUMPTION ON POD 1 OR 2 (P > 0.05). POSTOPERATIVE PRO IMPROVEMENTS FROM PREOPERATIVE SCORES ARE REPORTED IN TABLE 4. PREOPERATIVE VAS LEG SCORES WERE STATISTICALLY DIFFERENT BETWEEN COHORTS (P = 0.027). HOWEVER, PREOPERATIVE ODI AND VAS BACK SCORES DID NOT DIFFER BETWEEN GROUPS (P > 0.05). ADDITIONALLY, DEPO AND NODEPO GROUPS EXPERIENCED SIMILAR IMPROVEMENTS IN PROS AT ALL POSTOPERATIVE TIME POINTS. FURTHERMORE, PATIENTS IN BOTH COHORTS ACHIEVED MCID FOR ODI, VAS BACK, AND VAS LEG AT SIMILAR RATES (P > 0.05). DISCUSSION: COMPLICATIONS RELATED TO THE ADMINISTRATION OF LOCAL INTRAOPERATIVE STEROIDS REMAIN A CONSIDERATION WITH ITS ROUTINE USE. IN THE PRESENT STUDY A GREATER NUMBER OF COMPLICATIONS OCCURRED IN THE DEPO COHORT. THESE COMPLICATIONS INCLUDED 1 PATIENT WITH POSTOPERATIVE URINARY RETENTION, 2 PATIENTS WITH SUPERFICIAL WOUND INFECTIONS, AND 1 PATIENT REQUIRING A REPEAT OPERATION FOR SYMPTOMATIC PSEUDARTHROSIS. HOWEVER, THIS WAS NOT A STATISTICALLY SIGNIFICANT ASSOCIATION. THE AFOREMENTIONED STUDY BY AKINDURO ET AL. ALSO INVESTIGATED COMPLICATION RATES WITH INTRAOPERATIVE STEROID USE.1 IN A META-ANALYSIS, THE AUTHORS IDENTIFIED A TREND TOWARD HIGHER INFECTIOUS (0.94% VS 0.08%, P = 0.10) AND TOTAL COMPLICATION RATE (2.69% VS 1.18%, P = 0.19) AMONG THOSE RECEIVING INTRAOPERATIVE STEROIDS, ALTHOUGH THESE WERE NOT STATISTICALLY SIGNIFICANT. IT WAS SUGGESTED THAT THIS COULD BE DUE TO A LOW OVERALL COMPLICATION RATE ASSOCIATED WITH LUMBAR DISCECTOMY THAT PREVENTED STATISTICALLY SIGNIFICANT DIFFERENCES. THESE RESULTS, IN COMBINATION WITH THOSE OF THE PRESENT STUDY, INDICATE THE NEED FOR FURTHER INVESTIGATION TO BETTER CHARACTERIZE THE RELATIONSHIP BETWEEN INTRAOPERATIVE STEROID USE AND COMPLICATION RATES FOR MIS TLIF. NEVERTHELESS, BECAUSE THE CURRENT LITERATURE IS INCONCLUSIVE, IT WOULD BE PRUDENT FOR SURGEONS TO ASSESS THE POTENTIAL RISK FOR COMPLICATIONS WHEN CONSIDERING THE USE OF LOCAL INTRAOPERATIVE STEROIDS FOR MIS TLIF. CONCLUSIONS: LOCAL DEPOMEDROL APPLICATION DID NOT LEAD TO DECREASES IN ACUTE POSTOPERATIVE PAIN OR NARCOTICS CONSUMPTION AFTER MIS TLIF. ADDITIONALLY, LOCAL DEPOMEDROL ADMINISTRATION WAS NOT ASSOCIATED WITH POSTOPERATIVE IMPROVEMENTS IN PROS. FINALLY, ALTHOUGH THE USE OF DEPOMEDROL WAS ASSOCIATED WITH SMALL INCREASES IN COMPLICATION RATES, THIS WAS NOT STATISTICALLY SIGNIFICANT. THE FINDINGS OF THIS RANDOMIZED TRIAL SUGGEST THAT THE USE OF LOCAL INTRAOPERATIVE STEROIDS MAY NOT PROVIDE ADDITIONAL BENEFIT WITH REGARD TO SURGICAL AND CLINICAL OUTCOMES IN PATIENTS WHO UNDERGO MIS TLIF. HOWEVER, ADDITIONAL STUDIES ARE NEEDED TO FURTHER ASSESS LONG-TERM OUTCOMES AND COMPLICATION RISKS WITH THE USE OF LOCAL INTRAOPERATIVE STEROIDS IN LUMBAR FUSION PROCEDURES. FOLLOW UP (29JUN2020): THIS IS A REPORT FROM A NON-PFIZER SPONSORED INTERVENTIONAL STUDY SOURCE FOR PROTOCOL (B)(4). NEW INFORMATION INCLUDED: THE UDI WAS (B)(4) FOR ABSORBABLE GELATIN. SAMPLE STATUS WAS SAMPLE AVAILABILITY UNKNOWN. PHOTOS NOT AVAILABLE. SITE SAMPLE STATUS WAS NOT RECEIVED. SEVERITY OF HARM WAS S4. FAILURE MODE WAS POST-OPERATIVE INFECTION. SUMMARY OF INVESTIGATION /CONCLUSION: THERE WERE NO CORRECTIONS PERFORMED, OR CORRECTIVE OR PREVENTATIVE ACTIONS IDENTIFIED, AS A RESULT OF THIS COMPLAINT INVESTIGATION. INVESTIGATION OF THE COMPLAINT DID NOT DETERMINE THE REPORTED ISSUE TO BE PROCESS RELATED; THEREFORE, A CORRECTION, OR CORRECTIVE OR PREVENTATIVE ACTION, IS NOT REQUIRED FOR THIS CASE. ADDITIONALLY, A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF CORRECTIONS, OR CORRECTIVE OR PREVENTATIVE ACTIONS FOR THE REPORTED COMPLAINT. ALL REVIEWED RECORDS, TRENDS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. THERE IS NO INDICATION THAT THE DEVICES FAILED TO MEET REGISTERED SPECIFICATIONS. BASED UPON THE RESULTS OF THIS INVESTIGATION, THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. COMPANY CLINICAL EVALUATION COMMENT: THE REPORTED EVENT OF WOUND INFECTION IS UNLISTED IN THE CDS OF THE PFIZER SUSPECT PRODUCTS METHYLPREDNISOLONE ACETATE AND WAS ASSESSED AS RELATED BY THE REPORTER AND COMPANY. ON THE OTHER HAND, THE SAID EVENT IS ALSO UNLISTED IN THE CDS OF THE PFIZER SUSPECT PRODUCT ABSORBABLE GELATIN WHICH WAS ASSESSED AS RELATED BY THE REPORTER BUT UNRELATED BY THE COMPANY. BASED ON TEMPORAL RELATIONSHIP AND LIMITED INFORMATION AVAILABLE, A POSSIBLE CONTRIBUTORY ROLE OF THE SUSPECT DRUGS METHYLPREDNISOLONE ACETATE, CANNOT BE EXCLUDED FOR THE REPORTED EVENT OF WOUND INFECTION. THE SAID EVENT IS CONSIDERED UNRELATED TO ABSORBABLE GELATIN AS THE EVENT LIKELY REPRESENT INTERCURRENT MEDICAL CONDITIONS IN REFERENCE TO ABSORBABLE GELATIN. THIS CASE WILL BE REASSESSED WHEN ADDITIONAL INFORMATION IS RECEIVED. THE IMPACT OF THIS REPORT ON THE BENEFIT-RISK PROFILE OF THE PFIZER PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR AE. ANY SAFETY CONCERN IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTION IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE., COMMENT: THE REPORTED EVENT OF WOUND INFECTION IS UNLISTED IN THE CDS OF THE PFIZER SUSPECT PRODUCTS METHYLPREDNISOLONE ACETATE AND WAS ASSESSED AS RELATED BY THE REPORTER AND COMPANY. ON THE OTHER HAND, THE SAID EVENT IS ALSO UNLISTED IN THE CDS OF THE PFIZER SUSPECT PRODUCT ABSORBABLE GELATIN WHICH WAS ASSESSED AS RELATED BY THE REPORTER BUT UNRELATED BY THE COMPANY BASED ON TEMPORAL RELATIONSHIP AND LIMITED INFORMATION AVAILABLE, A POSSIBLE CONTRIBUTORY ROLE OF THE SUSPECT DRUGS METHYLPREDNISOLONE ACETATE, CANNOT BE EXCLUDED FOR THE REPORTED EVENT OF WOUND INFECTION. THE SAID EVENT IS CONSIDERED UNRELATED TO ABSORBABLE GELATIN AS THE EVENT LIKELY REPRESENT INTERCURRENT MEDICAL CONDITIONS IN REFERENCE TO ABSORBABLE GELATIN. THIS CASE WILL BE REASSESSED WHEN ADDITIONAL INFORMATION IS RECEIVED. THE IMPACT OF THIS REPORT ON THE BENEFIT-RISK PROFILE OF THE PFIZER PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR AE. ANY SAFETY CONCERN IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTION IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE.
SUPERFICIAL WOUND INFECTION [WOUND INFECTION], EFFECTS OF INTRAOPERATIVE LOCAL STEROID UTILIZATION IN A SINGLE-LEVEL MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION. THIS IS A NON-PFIZER SPONSORED INTERVENTIONAL STUDY, STUDY ID: NCT03308084, FROM J NEUROSURG SPINE 2019; 30:222-227, ENTITLED " IMPACT OF LOCAL STEROID APPLICATION IN A MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION: RESULTS OF A PROSPECTIVE, RANDOMIZED, SINGLE-BLIND TRIAL ". A SUBJECT OF UNSPECIFIED AGE AND GENDER WHO WAS RANDOMIZED INTO DEPOMEDROL (DEPO) COHORTS STARTED TO RECEIVE METHYLPREDNISOLONE ACETATE (DEPO-MEDROL) 80 MG, VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION AT 1 ML DEPOMEDROL (80 MG) APPLIED DIRECTLY TO THE SURGICAL SITE BY USING A GELFOAM CARRIER FOR AN UNSPECIFIED INDICATION, ABSORBABLE GELATIN (GELFOAM), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION BY USING A 10-CM2 GELFOAM CARRIER FOR AN UNSPECIFIED INDICATION. THE SUBJECT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE SUBJECT IN THE DEPO COHORT DEVELOPED SUPERFICIAL WOUND INFECTIONS IN THE FIRST 6 POSTOPERATIVE WEEKS THAT RESOLVED WITH ORAL ANTIBIOTIC THERAPY. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR METHYLPREDNISOLONE ACETATE WAS UNKNOWN, FOR ABSORBABLE GELATIN WAS UNKNOWN. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF SUPERFICIAL WOUND INFECTION WAS ORAL ANTIBIOTIC THERAPY. THE OUTCOME OF EVENT WAS RECOVERED. OBJECTIVE: LOCAL EPIDURAL STEROID APPLICATION MAY BE ASSOCIATED WITH DECREASED PAIN AND NARCOTIC USE IN THE IMMEDIATE POSTOPERATIVE PERIOD FOLLOWING LUMBAR DISCECTOMY. HOWEVER, LOCAL STEROID DELIVERY FOLLOWING LUMBAR FUSION PROCEDURES HAS NOT BEEN WELL CHARACTERIZED. THIS STUDY AIMS TO CHARACTERIZE THE EFFECT OF LOCAL INTRAOPERATIVE DEPOMEDROL APPLICATION ON PERIOPERATIVE AND POSTOPERATIVE OUTCOMES FOLLOWING A SINGLE-LEVEL MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (MIS TLIF). METHODS: A PROSPECTIVE, RANDOMIZED, SINGLE-BLINDED STUDY WAS PERFORMED. A PRIORI POWER ANALYSIS DETERMINED THAT 86 PATIENTS WERE NEEDED TO DETECT A DIFFERENCE OF 1 POINT IN THE VISUAL ANALOG SCALE (VAS) PAIN SCORE BETWEEN GROUPS. NINETY-THREE PATIENTS WERE RANDOMIZED INTO DEPOMEDROL (DEPO) AND NO DEPOMEDROL (NODEPO) COHORTS. PRIOR TO SURGICAL CLOSURE, DEPO PATIENTS RECEIVED 1 ML DEPOMEDROL (80 MG) APPLIED DIRECTLY TO THE SURGICAL SITE BY USING A GELFOAM CARRIER. NODEPO PATIENTS RECEIVED 1 ML SALINE ON THE SAME GELFOAM CARRIER. PERIOPERATIVE OUTCOMES INCLUDING ACUTE POSTOPERATIVE PAIN AND NARCOTIC USE WERE ASSESSED FOR THE DURATION OF INPATIENT STAY. PATIENT-REPORTED OUTCOMES (PROS) QUESTIONNAIRES INCLUDING VAS BACK AND LEG PAIN SCORES, AND OSWESTRY DISABILITY INDEX (ODI) WERE ADMINISTERED PREOPERATIVELY AND AT 6-WEEK, 12-WEEK, AND 6-MONTH FOLLOW-UP. OUTCOMES FOR DEPO AND NODEPO COHORTS WERE COMPARED USING LINEAR REGRESSION CONTROLLED FOR SEX. RESULTS: A TOTAL OF 105 PATIENTS WERE ENROLLED AND RANDOMIZED TO THE DEPO (N = 52) OR NODEPO COHORTS (N = 53). FOUR PATIENTS IN THE DEPO COHORT INADVERTENTLY RECEIVED ONLY A 40-MG INJECTION OF DEPOMEDROL, AND THEREFORE WERE EXCLUDED FROM ANALYSIS. AN ADDITIONAL 8 PATIENTS WERE EXCLUDED FROM FINAL ANALYSIS DUE TO INCOMPLETE POSTOPERATIVE SURVEY COMPLETION (3 IN DEPO, 5 IN NODEPO). THEREFORE, 93 PATIENTS WERE INCLUDED IN THE FINAL ANALYSIS, OF WHICH 45 (48.4%) AND 48 (51.6%) WERE IN DEPO AND NODEPO GROUPS, RESPECTIVELY. A GREATER PERCENTAGE OF DEPO PATIENTS WERE FEMALE (53.3% VS 27.1%, P = 0.010). NO SIGNIFICANT DIFFERENCES IN PREOPERATIVE CHARACTERISTICS WERE IDENTIFIED BETWEEN GROUPS (P > 0.05). PERIOPERATIVE CHARACTERISTICS AND COMPLICATION RATES ARE DESCRIBED IN TABLE 2. PATIENTS IN THE DEPO AND NODEPO COHORT EXHIBITED SIMILAR OPERATING TIMES AND INTRAOPERATIVE BLOOD LOSS. THE LOS AND POSTOPERATIVE DAY OF DISCHARGE WERE ALSO FOUND TO BE SIMILAR BETWEEN GROUPS. ONE PATIENT IN THE DEPO COHORT EXPERIENCED POSTOPERATIVE URINARY RETENTION, REQUIRING A URINARY CATHETER UPON DISCHARGE AND FOLLOW-UP WITH UROLOGY. IN ADDITION, 2 PATIENTS IN THE DEPO GROUP DEVELOPED SUPERFICIAL WOUND INFECTIONS IN THE FIRST 6 POSTOPERATIVE WEEKS THAT RESOLVED WITH ORAL ANTIBIOTIC THERAPY. LAST, 1 PATIENT IN THE DEPO COHORT DEVELOPED SYMPTOMATIC PSEUDARTHROSIS, WHICH REQUIRED AN ANTERIOR LUMBAR INTERBODY FUSION AT THE INDEX LEVEL APPROXIMATELY 18 MONTHS POSTOPERATIVELY. NO COMPLICATIONS WERE OBSERVED IN THE NODEPO COHORT. STATISTICALLY SIGNIFICANT DIFFERENCES BETWEEN GROUPS FOR COMPLICATION RATES WERE NOT IDENTIFIED (P > 0.05 FOR EACH). INPATIENT PAIN SCORES AND NARCOTICS CONSUMPTION ARE DESCRIBED IN TABLE 3. NO DIFFERENCES IN ACUTE POSTOPERA- OBSERVED BETWEEN DEPO AND NODEPO GROUPS (P > 0.05). PATIENTS IN THE DEPO COHORT CONSUMED FEWER HOURLY NARCOTICS ON POD 0 (5.3 VS 6.3 OMES/HOUR, P = 0.034). HOWEVER, THERE WERE NO DIFFERENCES BETWEEN GROUPS IN HOURLY NARCOTICS CONSUMPTION ON POD 1 OR 2 (P > 0.05). POSTOPERATIVE PRO IMPROVEMENTS FROM PREOPERATIVE SCORES ARE REPORTED IN TABLE 4. PREOPERATIVE VAS LEG SCORES WERE STATISTICALLY DIFFERENT BETWEEN COHORTS (P = 0.027). HOWEVER, PREOPERATIVE ODI AND VAS BACK SCORES DID NOT DIFFER BETWEEN GROUPS (P > 0.05). ADDITIONALLY, DEPO AND NODEPO GROUPS EXPERIENCED SIMILAR IMPROVEMENTS IN PROS AT ALL POSTOPERATIVE TIME POINTS. FURTHERMORE, PATIENTS IN BOTH COHORTS ACHIEVED MCID FOR ODI, VAS BACK, AND VAS LEG AT SIMILAR RATES (P > 0.05). COMPLICATIONS RELATED TO THE ADMINISTRATION OF LOCAL INTRAOPERATIVE STEROIDS REMAIN A CONSIDERATION WITH ITS ROUTINE USE. IN THE PRESENT STUDY A GREATER NUMBER OF COMPLICATIONS OCCURRED IN THE DEPO COHORT. THESE COMPLICATIONS INCLUDED 1 PATIENT WITH POSTOPERATIVE URINARY RETENTION, 2 PATIENTS WITH SUPERFICIAL WOUND INFECTIONS, AND 1 PATIENT REQUIRING A REPEAT OPERATION FOR SYMPTOMATIC PSEUDARTHROSIS. HOWEVER, THIS WAS NOT A STATISTICALLY SIGNIFICANT ASSOCIATION. THE AFOREMENTIONED STUDY BY AKINDURO ET AL. ALSO INVESTIGATED COMPLICATION RATES WITH INTRAOPERATIVE STEROID USE. 1 IN A META-ANALYSIS, THE AUTHORS IDENTIFIED A TREND TOWARD HIGHER INFECTIOUS (0.94% VS 0.08%, P = 0.10) AND TOTAL COMPLICATION RATE (2.69% VS 1.18%, P = 0.19) AMONG THOSE RECEIVING INTRAOPERATIVE STEROIDS, ALTHOUGH THESE WERE NOT STATISTICALLY SIGNIFICANT. IT WAS SUGGESTED THAT THIS COULD BE DUE TO A LOW OVERALL COMPLICATION RATE ASSOCIATED WITH LUMBAR DISCECTOMY THAT PREVENTED STATISTICALLY SIGNIFICANT DIFFERENCES. THESE RESULTS, IN COMBINATION WITH THOSE OF THE PRESENT STUDY, INDICATE THE NEED FOR FURTHER INVESTIGATION TO BETTER CHARACTERIZE THE RELATIONSHIP BETWEEN INTRAOPERATIVE STEROID USE AND COMPLICATION RATES FOR MIS TLIF. NEVERTHELESS, BECAUSE THE CURRENT LITERATURE IS INCONCLUSIVE, IT WOULD BE PRUDENT FOR SURGEONS TO ASSESS THE POTENTIAL RISK FOR COMPLICATIONS WHEN CONSIDERING THE USE OF LOCAL INTRAOPERATIVE STEROIDS FOR MIS TLIF. CONCLUSIONS: LOCAL DEPOMEDROL APPLICATION DID NOT LEAD TO DECREASES IN ACUTE POSTOPERATIVE PAIN OR NARCOTICS CONSUMPTION AFTER MIS TLIF. ADDITIONALLY, LOCAL DEPOMEDROL ADMINISTRATION WAS NOT ASSOCIATED WITH POSTOPERATIVE IMPROVEMENTS IN PROS. FINALLY, ALTHOUGH THE USE OF DEPOMEDROL WAS ASSOCIATED WITH SMALL INCREASES IN COMPLICATION RATES, THIS WAS NOT STATISTICALLY SIGNIFICANT. THE FINDINGS OF THIS RANDOMIZED TRIAL SUGGEST THAT THE USE OF LOCAL INTRAOPERATIVE STEROIDS MAY NOT PROVIDE ADDITIONAL BENEFIT WITH REGARD TO SURGICAL AND CLINICAL OUTCOMES IN PATIENTS WHO UNDERGO MIS TLIF. HOWEVER, ADDITIONAL STUDIES ARE NEEDED TO FURTHER ASSESS LONG-TERM OUTCOMES AND COMPLICATION RISKS WITH THE USE OF LOCAL INTRAOPERATIVE STEROIDS IN LUMBAR FUSION PROCEDURES. COMPANY CLINICAL EVALUATION COMMENT: THE REPORTED EVENT OF WOUND INFECTION IS UNLISTED IN THE CDS OF THE PFIZER SUSPECT PRODUCTS METHYLPREDNISOLONE ACETATE AND WAS ASSESSED AS RELATED BY THE REPORTER AND COMPANY. ON THE OTHER HAND, THE SAID EVENT IS ALSO UNLISTED IN THE CDS OF THE PFIZER SUSPECT PRODUCT ABSORBABLE GELATIN WHICH WAS ASSESSED AS RELATED BY THE REPORTER BUT UNRELATED BY THE COMPANY BASED ON TEMPORAL RELATIONSHIP AND LIMITED INFORMATION AVAILABLE, A POSSIBLE CONTRIBUTORY ROLE OF THE SUSPECT DRUGS METHYLPREDNISOLONE ACETATE, CANNOT BE EXCLUDED FOR THE REPORTED EVENT OF WOUND INFECTION. THE SAID EVENT IS CONSIDERED UNRELATED TO ABSORBABLE GELATIN AS THE EVENT LIKELY REPRESENT INTERCURRENT MEDICAL CONDITIONS IN REFERENCE TO ABSORBABLE GELATIN. THIS CASE WILL BE REASSESSED WHEN ADDITIONAL INFORMATION IS RECEIVED. THE IMPACT OF THIS REPORT ON THE BENEFIT-RISK PROFILE OF THE PFIZER PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR AE. ANY SAFETY CONCERN IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTION IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE. THE REPORTED EVENT OF WOUND INFECTION IS UNLISTED IN THE CDS OF THE PFIZER SUSPECT PRODUCTS METHYLPREDNISOLONE ACETATE AND WAS ASSESSED AS RELATED BY THE REPORTER AND COMPANY. ON THE OTHER HAND, THE SAID EVENT IS ALSO UNLISTED IN THE CDS OF THE PFIZER SUSPECT PRODUCT ABSORBABLE GELATIN WHICH WAS ASSESSED AS RELATED BY THE REPORTER BUT UNRELATED BY THE COMPANY. BASED ON TEMPORAL RELATIONSHIP AND LIMITED INFORMATION AVAILABLE, A POSSIBLE CONTRIBUTORY ROLE OF THE SUSPECT DRUGS METHYLPREDNISOLONE ACETATE, CANNOT BE EXCLUDED FOR THE REPORTED EVENT OF WOUND INFECTION. THE SAID EVENT IS CONSIDERED UNRELATED TO ABSORBABLE GELATIN AS THE EVENT LIKELY REPRESENT INTERCURRENT MEDICAL CONDITIONS IN REFERENCE TO ABSORBABLE GELATIN. THIS CASE WILL BE REASSESSED WHEN ADDITIONAL INFORMATION IS RECEIVED. THE IMPACT OF THIS REPORT ON THE BENEFIT-RISK PROFILE OF THE PFIZER PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR AE. ANY SAFETY CONCERN IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTION IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 518123 | GELFOAM | SPONGE, STERILE; CLASS III | LMF | PFIZER, INC. (DEVICE) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |