BIOZORB
Report
- Report Number
- 1222780-2023-00289
- Event Type
- Injury
- Date Received
- September 5, 2023
- Date of Event
- August 2, 2018
- Report Date
- May 20, 2025
- Manufacturer
- HOLOGIC, INC
- Product Code
- NEU
- UDI-DI
- 00851766006061
- PMA / PMN Number
- K143484
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
Narratives
HOLOGIC IS SUBMITTING THIS REPORT IN ACCORDANCE WITH 21. CFR PART 803. THE SUBMISSION IS BASED UPON THE CURRENTLY AVAILABLE INFORMATION. THE SUBMISSION OF THIS REPORT DOES NOT REPRESENT A CONFIRMATION OF DEVICE MALFUNCTION INVOLVING THE HOLOGIC PRODUCTS IN THE EVENT DESCRIBED. D4: LOT AND SERIAL NUMBER OF THE DEVICE NOT PROVIDED BY THE COMPLAINANT; THEREFORE, THE UDI, EXPIRATION AND MANUFACTURING DATES ARE NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICE AS THE IDENTIFICATION NUMBERS WERE NOT PROVIDED BY THE COMPLAINANT. H3: THE DEVICE INVOLVED IN THIS EVENT WAS NOT RETURNED FOR EVALUATION PURPOSES THEREFORE VISUAL AND FUNCTIONAL ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED. WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE DEVICE AND THE ISSUE REPORTED AND A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE INFORMATION OBTAINED DURING COMPLAINT INVESTIGATION WILL BE INCLUDED IN OUR GLOBAL COMPLAINT TRENDING AND PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS TYPE FOR ADVERSE TRENDS. IF THE PRODUCT IS RECEIVED OR ADDITIONAL INFORMATION IS OBTAINED, THE INVESTIGATION WILL BE REOPENED ACCORDINGLY PER STANDARD OPERATING PROCEDURE.
AFTER ADDITIONAL MEDICAL REVIEW IT WAS DETERMINED THAT A 60 YEARS OLD, 161 LBS. AND BMI 29 IN (B)(6) 2018, PATIENT UNDERWENT LEFT PARTIAL MASTECTOMY WITH SENTINEL BIOPSY AND 2X2X1 BIOZORB PLACEMENT (2X2X1CM, MODEL: F0221, LOT: H1-180410). PATHOLOGY REVEALED: 1.5CM, INVASIVE DUCTAL CARCINOMA, GRADE 2, WITH NEGATIVE MARGINS AND 2 NEGATIVE SENTINEL LYMPH NODES. PATIENT RECEIVED RADIATION THERAPY COMPLETED (B)(6) 2018, AND ANASTRAZOLE. THE FIRST OFFICE VISIT NOTE IS FROM (B)(6) 2022 APPROXIMATELY 4 YEARS POST IMPLANT, THIS NOTES PAIN AT "0/10". THERE IS NO NOTE OF ANY BREAST COMPLAINTS. THERE IS A NOTE OF HOSPITALIZATION FOR RIGHT HEART FAILURE/RESPIRATORY ISSUES. OFFICE VISIT (B)(6) 2022 ALSO W 0/10 PAIN AND NO NOTE OF ANY BREAST RELATED COMPLAINTS. LEFT BREAST MAMMOGRAM & ULTRASOUND REPORT, (B)(6)2023, OVER 5 YEARS POST IMPLANT, NOTES INDICATION FOR EXAM IS "LEFT BREAST PAIN". ULTRASOUND RESULT AT THIS VISIT NOTE, "SONOGRAPHIC IMAGING OF THE LATERAL ASPECT OF THE LEFT BREAST AT SITE OF PAIN IS NORMAL. THERE IS NO CYST. NO SOLID OR SUSPICIOUS SONOGRAPHIC FINDING." MAMMOGRAM NOTES, "SCATTERED AREAS OF FIBROGLANDULAR DENSITY IN THE LEFT BREAST. BIOZORB MATERIAL IN THE UPPER OUTER QUADRANT LEFT BREAST AT THE SITE OF PREVIOUS LUMPECTOMY. SURGICAL CLIPS IN LEFT AXILLA. MAMMOGRAM IS OTHERWISE UNREMARKABLE." AT AN OFFICE VISIT, (B)(6)2023 MORE THAN 4YEARS POST IMPLANT, THE PATIENT REPORTED PAIN IN LEFT BREAST, UPPER LEFT BACK AND THORAX. PER VISIT NOTE, PATIENT WAS IN HER USUAL STATE OF HEALTH TILL AROUND FIRST OF JANUARY WHEN SHE BEGAN HAVING PAIN AND FULLNESS OF LEFT UPPER OUTER QUADRANT OF BREAST WORSENED WITH ARM MOVEMENT COUGH/SNEEZE AND DEEP BREATHING, THERE WERE NO RESPIRATORY SYMPTOMS REPORTED. PER PRIMARY CARE DOCTOR, "SHE SAW HER ONCOLOGIST WHO FELT THERE WAS NOTHING IN THE BREAST AND THAT THERE WAS NOTHING TO WORRY ABOUT." LEFT LATERAL BREAST TENDERNESS NOTED ON EXAM. THE PCP ORDERED A CHEST X-RAY WHICH WAS UNREMARKABLE. THE PCP CONCLUDED "I DO NOT FEEL THIS (BREAST PAIN) IS RELATED TO LYMPHEDEMA IN THAT BREAST OR SPECIFICALLY TO HER BREAST CANCER. SHE MAY WANT TO TRY USING GOOD SUPPORTIVE UNDERGARMENTS.¿ THE PCP FELT THE LEFT WALL CHEST PAIN WAS PLEURITIC IN NATURE AND HELD THE ALENDRONATE, IN CASE THERE WAS A GI COMPONENT TO THE PAIN, AND PRESCRIBED CELECOXIB. FOLLOW UP VISIT APPROXIMATELY 1 MONTH LATER NOTES THE "...SEVERE PAIN SHE HAD IN THE LEFT SIDE OF HER BREAST IS IMPROVING." THE CLINICIAN SUGGESTED THIS MAY BE RELATED TO REFERRED ESOPHAGEAL PAIN FROM ALENDRONATE. THE PCP DECIDED TO KEEP HER OFF THE ALENDRONATE AS PAIN WAS IMPROVING AND REFER TO ONCOLOGIST. IN (B)(6) 2023, PATIENT WENT BACK TO HER PCP FOR CONTINUED DISCOMFORT IN HER LEFT BREAST. BREAST PAIN HAD BEEN IMPROVING WITH CELECOXIB BUT THEN INCREASED. PATIENT REPORTED, "SHE HAS BEEN DOING RESEARCH ON HER OWN AND IS CONCERNED THAT THE BIOZORB COULD BE THE ISSUE. PCP NOTES THAT THE PATIENT, "HAD MAMMOGRAMS DONE WHICH WERE EXTENSIVE AND DID NOT SHOW ANY ABNORMALITIES." THE PCP DECIDED TO RESTART THE ALENDRONATE AND REFER THE PATIENT TO SURGERY AND ONCOLOGY. VISIT WITH SURGEON, (B)(6)2023, MORE THAN 4 YEARS POST IMPLANT NOTES, THE PAIN DEVELOPED NEW LEFT BREAST PAIN IN (B)(6) 2022 AND WAS EVALUATED BY PCP, PULMONOLOGIST AND CARDIOLOGIST, WORK UPS DID NOT REVEAL A DEFINITIVE CAUSE. THE PATIENT HAD TRIED 30 DAYS OF CELECOXIB WHICH HELPED. PAIN WAS ALSO RELIEVED BY USE OF A COMPRESSION BRA. EXAM AT THIS VISIT NOTED, "NO VISIBLE OR PALPABLE EVIDENCE OF RECURRENT BREAST CANCER IN LEFT BREAST, EXPECTED XRT CHANGES TO SKIN AND SOFT TISSUES OF LEFT BREAST. SCAR LATERAL LEFT BREAST. BIOZORB REMNANTS ARE NOT PALPABLE. LOWER POLE TENDERNESS WITHOUT ERYTHEMA, INDURATION, FLUCTUANCE OR WARMTH." THE SURGEON CONCLUDED, "HER LEFT MASTODYNIA MAY BE A LATE EFFECT OF RADIATION THERAPY AND IS LESS LIKELY DUE TO THE BIOZORB DEVICE PLACED IN 2018. I WOULD RECOMMEND TOPICAL DICLOFENAC...SHE WILL BE SEEING HER PRIMARY BREAST SURGEON.¿ AT VISIT WITH ONCOLOGIST (B)(6)2023, PATIENT REPORTED LEFT BREAST PAIN WITHOUT PALPABLE LUMPS AND THAT "THIS SEEMS TO BE IMPROVING OVERALL." NO ADDITIONAL DIAGNOSIS OR TREATMENT GIVEN. VISIT WITH PCP (B)(6) 2023, NOTES, THE PATIENT "...WAS HAVING SOME ISSUES WITH BREAST DISCOMFORT AND SAY THAT THE PHYSICIAN WHO TOLD HER THAT HE FELT THIS WAS CHRONIC INJURY ASSOCIATED WITH THE PREVIOUS RADIATION AND SURGERY AND HE DID NOT THINK IT WAS THE MESH." NO OTHER NOTE OF BREAST RELATED COMPLAINTS AT THIS VISIT. ONCOLOGY VISIT (B)(6)2023, PATIENT DENIES PAIN, LUMPS, OR SWELLING. NO TENDERNESS OR LUMP NOTED ON EXAM. MEDICAL HISTORY: FEMALE WITH A HISTORY OF TOBACCO USE, CHRONIC BRONCHITIS, OSTEOPOROSIS, TYPE 2 DIABETES MELLITUS, RIGHT SIDED HEART FAILURE, NOCTURNAL HYPOXIA REQUIRING SUPPLEMENTAL HOME OXYGEN, HYPERLIPIDEMIA, PULMONARY NODULE, AND DRUG ALLERGIES HAD AN ABNORMAL SCREENING MAMMOGRAM. THERE ARE NO MEDICAL RECORDS AVAILABLE FROM TIME OF DIAGNOSIS. ONCOLOGY NOTE FROM 5 YEARS POST DIAGNOSIS NOTES INVASIVE DUCTAL CARCINOMA, LEFT BREAST UPPER OUTER QUADRANT, STAGE 1A, T1CPN0M0, ER/PR+, HER1/NEU-. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT/SERIAL NUMBER. THE DEVICE WAS RELEASED MEETING ALL QA SPECIFICATIONS.
IT WAS REPORTED THAT ON (B)(6) 2018 A BIOZORB WAS IMPLANTED IN THE PATIENT, AND THE PATIENT REPORTED THAT SUFFERS FROM A HARD, PALPABLE LUMP AT THE SITE OF THE BIOZORB, ALSO REPORTED THAT SUFFERS FROM CONSTANT, SEVERE PAIN, TENDERNESS, SENSITIVITY, AND DISCOMFORT IN THE AREA OF THE DEVICE, PAIN WHEN SLEEPING ON HER LEFT SIDE AND SUFFERS FROM PAIN ANY TIME SHE NEEDS TO MOVE HER HAND AND ARM ABOVE HER SHOULDERS, SEVERELY LIMITING HER MOBILITY. NO INITIAL EVALUATION COULD BE PERFORMED BECAUSE THERE WAS NO RETURNED SAMPLE FOR THIS COMPLAINT. THE SAMPLE WAS NOT RETURNED FOR THIS COMPLAINT AND THERE WAS LIMITED PATIENT-RELATED INFORMATION PROVIDED FOR THIS EVENT; THEREFORE, A THOROUGH INVESTIGATION WAS NOT ABLE TO BE PERFORMED. INVESTIGATION INTO SEVERAL OF THE HARMS REPORTED IN THIS COMPLAINT WAS PERFORMED FROM A CLINICAL LITERATURE REVIEW, AS WELL AS AN INVESTIGATION INTO THE DESIGN AND RISK OF THE BIOZORB PRODUCT. THE HARMS IDENTIFIED DURING THIS COMPLAINT ARE: LIMITED MOBILITY, PAIN, DEVICE PALPABLE, SLEEP DYSFUNCTION. A REVIEW OF CLINICAL LITERATURE PERFORMED ON LUMPECTOMIES AND THEIR ASSOCIATED COMPLICATIONS WAS PERFORMED. A SUMMARY OF THIS REVIEW CONCLUDED THAT, WHILE LUMPECTOMY IS A WELL-ESTABLISHED OPTION FOR BREAST CANCER TREATMENT, IT INHERENTLY CARRIES RISKS OF COMPLICATIONS, MOST NOTABLY INFECTIONS, SEROMA FORMATION, CHRONIC PAIN, AND WOUND HEALING ISSUES. THE LITERATURE DEMONSTRATES VARIATION IN COMPLICATION RATES BASED ON SURGICAL TECHNIQUE, ADDITIONAL THERAPIES (SUCH AS INTRAOPERATIVE RADIATION THERAPY (IORT) OR RADIATION), AND INDIVIDUAL PATIENT FACTORS, WITH INFECTION RATES RANGING FROM 2% TO 10% AND SEROMA RATES FROM 11% TO 65%. PAIN: BIOZORB (0.9% TO 1.9%): PAIN OR DISCOMFORT WAS REPORTED IN 0.9% TO 1.9% OF PATIENTS WITH THE BIOZORB MARKER. IN ONE INSTANCE, DISCOMFORT OCCURRED DUE TO THE DEVICE BEING SUTURED TO THE SERRATUS MUSCLE BUT DID NOT RESULT IN REMOVAL. IN ANOTHER STUDY, DISCOMFORT IN 1.1% OF PATIENTS LED TO DEVICE REMOVAL. HOWEVER, GIVEN THAT PAIN IS A WELL-KNOWN COMPLICATION FOLLOWING LUMPECTOMY, PARTICULARLY IN CASES WITH NERVE DAMAGE OR RADIATION THERAPY, SOME OF THIS DISCOMFORT COULD BE ATTRIBUTED TO THE INITIAL SURGICAL INTERVENTION RATHER THAN THE PRESENCE OF THE MARKER. LUMPECTOMY (25% TO 60%): CHRONIC PAIN IS A FREQUENT LONG-TERM COMPLICATION OF LUMPECTOMY, AFFECTING 25% TO 60% OF BREAST CANCER SURGERY SURVIVORS. KWEE ET AL. REPORTED A POOLED PREVALENCE OF 31% FOR NEUROPATHIC PAIN FOLLOWING BCS. THE PRESENCE OF POST-SURGICAL PAIN, PARTICULARLY NEUROPATHIC PAIN CAUSED BY NERVE DAMAGE, COULD BE EXACERBATED BY OR MISATTRIBUTED TO THE BIOZORB MARKER IN SOME CASES. INFLAMMATION / SWELLING / LYMPHEDEMA / LIMITED MOBILITY : BIOZORB (0.7%): TISSUE DAMAGE, INCLUDING WOUND DEHISCENCE AND EROSION, WAS REPORTED IN 0.7% OF PATIENTS WITH THE BIOZORB MARKER. IN A MORE SEVERE CASE, THE BIOZORB DEVICE ERODED INTO THE NIPPLE-AREOLA COMPLEX, NECESSITATING COMPLETE REMOVAL OF THE NIPPLE-AREOLA COMPLEX DUE TO CHRONIC INFLAMMATION. HOWEVER, GIVEN THAT WOUND HEALING ISSUES, TISSUE NECROSIS, AND OTHER DAMAGE ARE KNOWN COMPLICATIONS OF LUMPECTOMY ITSELF, SOME OF THESE OUTCOMES COULD BE DIRECTLY RELATED TO THE SURGICAL TRAUMA AND HEALING PROCESS RATHER THAN THE DEVICE. LUMPECTOMY (13.1% OF PATIENTS, DELAYED HEALING IN 6.5%, AND SKIN-FLAP NECROSIS IN 1.1%, INDICATING THAT TISSUE DAMAGE): WOUND HEALING ISSUES AND TISSUE NECROSIS ARE COMMON AFTER LUMPECTOMY, PARTICULARLY IN CASES WHERE LARGE AMOUNTS OF TISSUE ARE REMOVED OR ADDITIONAL PROCEDURES SUCH AS RADIATION ARE PERFORMED. KNOWLES ET AL. REPORTED WOUND INFECTION IN 13.1% OF PATIENTS, DELAYED HEALING IN 6.5%, AND SKIN-FLAP NECROSIS IN 1.1%, INDICATING THAT TISSUE DAMAGE CAN BE A LUMPECTOMY-RELATED ISSUE. REGARDING LUMPECTOMY¿S, BERGER ET AL. (BERGER L, GRIMM A, SUTTERLIN M, ET AL. MAJOR COMPLICATIONS AFTER INTRAOPERATIVE RADIOTHERAPY WITH LOW-ENERGY X-RAYS IN EARLY BREAST CANCER. STRAHLENTHER ONKOL. APR 2024;200(4):276-286. DOI:10.1007/S00066-023-02128-Z) RETROSPECTIVELY ANALYZED THE OCCURRENCE OF SEVERE LOCAL COMPLICATIONS IN 10 OUT OF 408 WOMEN WHO UNDERWENT INTRAOPERATIVE RADIOTHERAPY (IORT) WITH LOW-ENERGY X-RAYS DURING BREAST-CONSERVING SURGERY (BCS) FOR EARLY BREAST CANCER BETWEEN 2002 AND 2017. THE COMPLICATIONS, WHICH REQUIRED SURGICAL INTERVENTION, INCLUDED REDNESS (80%), SEROMA (60%), WOUND INFECTION (60%), SUTURE DEHISCENCE (60%), AND INDURATION (40%). HEMATOMA AND NECROSIS WERE LESS COMMON (10% EACH). THESE SYMPTOMS EMERGED FROM IMMEDIATELY POST-OPERATION UP TO 15 YEARS LATER, WITH A MEDIAN ONSET AT 3.1 MONTHS. WHILE MOST COMPLICATIONS WERE MANAGED WITH SMALLER SURGICAL INTERVENTIONS, SUCH AS EXCISION OF NECROTIC AREAS OR SECONDARY SUTURES, MORE SEVERE CASES REQUIRED COMPLEX FLAP SURGERY OR MASTECTOMY. THE STUDY CONCLUDED THAT ALTHOUGH IORT IS GENERALLY SAFE, IT CARRIES A RISK OF SEVERE COMPLICATIONS. PREOPERATIVE COUNSELING AND VIGILANT FOLLOW-UP ARE RECOMMENDED TO MANAGE THESE RISKS EFFECTIVELY. CHRONIC PAIN, PARTICULARLY NEUROPATHIC PAIN, AFFECTS NEARLY ONE-THIRD OF PATIENTS. (KWEE ET AL. (2024)), MIGRATION CAN BE INFLUENCED BY SEVERAL PATIENT RELATED FACTORS WHICH CAN INFLUENCE THE LIKELIHOOD OF MIGRATION AFTER LUMPECTOMY, SUCH AS BREAST DENSITY, BIOPSY LOCATION, AND BIOPSY APPROACH. PER A STUDY BY ASHALI JAIN ET AL. (2017), MARKER MIGRATION IS A RELATIVELY COMMON OCCURRENCE FOLLOWING STEREOTACTIC BIOPSIES, HAPPENING IN 13% OF CASES. SWELLING IS ONE OF THE EXPECTED EVENTS THAT COULD OCCUR AFTER SURGERY AND/OR RADIATION THERAPY REGARDLESS OF THE USE OF A BIOZORB DEVICE. DUE TO THIS, CONFIRMATION OF THE SWELLING DURING THIS EVENT AS A NORMAL COURSE OF SURGERY VS BEING CAUSED BY THE BIOZORB IS NOT ABLE TO BE DONE. DEVICE EXPLANTATION IS BASED ON THE PATIENT¿S PHYSICIAN¿S EVALUATION OF THEIR PHYSICAL AND HEALTH STATE AND RECOMMENDATION; THEREFORE, AN INVESTIGATION INTO THIS INTERVENTION IS NOT ABLE TO BE PERFORMED FOR THIS COMPLAINT.THOUGH COMPLICATIONS ARE RELATIVELY COMMON, MOST ARE MANAGEABLE WITH APPROPRIATE POSTOPERATIVE CARE, MAKING LUMPECTOMY A VIABLE OPTION FOR MANY BREAST CANCER PATIENTS WHEN CAREFULLY MONITORED AND FOLLOWED UP. AN INVESTIGATION WAS PERFORMED BY SUBJECT MATTER EXPERTS (SME¿S) INTO SEVERAL OF THE HARMS IDENTIFIED AS BEING EXPERIENCED BY THE PATIENT RELATED TO DESIGN, RISK MANAGEMENT, AND CLINICAL FACTORS. THE RESULTS OF THESE INVESTIGATIONS AND POTENTIAL CAUSES CAN BE SEEN BELOW; HOWEVER, IT IS IMPORTANT TO NOTE THAT THESE RESULTS DO NOT INCLUDE MEDICAL INPUT FROM A QUALIFIED MEDICAL PROFESSIONAL: PAIN: THERE IS A LACK OF MIGRATION REQUIREMENTS AND TESTING TO EVALUATE IF THE DEVICE CAN CAUSE TISSUE DAMAGE DUE TO MIGRATION. VERIFICATION OF MECHANICAL STRENGTH AND SIMULATED USE IS NOT ADEQUATE DUE TO SEVERAL OPPORTUNITIES RELATED TO SAMPLING SIZE AND TEST METHODS. THE CRYSTALLINE PROPORTION IN THE DEVICE IS UNKNOWN. CRYSTALLINITY MAY BE CAUSING IRRITATION AND FOREIGN BODY REACTION CONSIDERING THE LONG PERIOD OF ABSORPTION OF THE DEVICE. THERE IS A LACK OF USABILITY TESTING EVALUATING THE USER NEEDS, SO THERE IS NO ASSURANCE THAT THE SURGICAL METHODS BEING USED FOR THE USERS ARE ADEQUATE. THERE IS A LACK OF ADEQUATE USER NEEDS TO CAPTURE APPROPRIATE DESIGN INPUTS, AND THEREFORE THERE ARE OPPORTUNITIES IN DESIGN OUTPUTS AND V&V ACTIVITIES. MIGRATION: THERE IS A LACK OF MIGRATION REQUIREMENTS AND TESTING TO EVALUATE IF THE DEVICE CAN CAUSE TISSUE DAMAGE DUE TO MIGRATION. THE CRYSTALLINE PROPORTION IN THE DEVICE IS UNKNOWN. HIGH CRYSTALLINITY MAY BE CAUSING MIGRATION/EROSION CONSIDERING THE LONG PERIOD OF ABSORPTION OF THE DEVICE. VERIFICATION OF MECHANICAL STRENGTH AND SIMULATED USE IS NOT ADEQUATE DUE TO SEVERAL OPPORTUNITIES RELATED TO SAMPLING SIZE AND TEST METHODS. THERE IS A LACK OF USABILITY TESTING EVALUATING THE USER NEEDS, SO THERE IS NO ASSURANCE THAT THE SURGICAL METHODS BEING USED FOR THE USERS ARE ADEQUATE. THERE IS A LACK OF ADEQUATE USER NEEDS TO CAPTURE APPROPRIATE DESIGN INPUTS. BASED ON THE CLINICAL LITERATURE REVIEW, THE HARMS REPORTED TO BE EXPERIENCED BY THE PATIENT IN THE COMPLAINT ARE COMMON SYMPTOMS FROM SURGERY AND LUMPECTOMIES; THEREFORE, A CONFIRMATION OF THE BIOZORB CAUSING THE HARMS WAS NOT ABLE TO BE DONE. HOWEVER, BASED ON THE REVIEW OF THE TOP HARMS IN REGARDS TO THE BIOZORB DESIGN AND RISK DOCUMENTATION, THE ADVERSE EVENTS REPORTED CAN BE TRACKED BACK TO A POTENTIAL SHARED CAUSE: LACK OF ADEQUATE USER NEEDS FOR THE PRODUCT. USER NEEDS DEFINE THE FRAMEWORK FOR PRODUCT DEVELOPMENT AND LAY THE GROUND FOR THE DEFINITION OF DESIGN INPUTS, DESIGN OUTPUTS AND LATER VERIFICATION AND VALIDATION ACTIVITIES. OTHER POTENTIAL CAUSES ARE RELATED TO INADEQUATE TEST METHODS AND/OR THE LACK OF EVIDENCE TO SUPPORT SOME SPECIFIC PRODUCT REQUIREMENTS. CONCLUSION: WHEN COMPARING THE SAFETY OUTCOMES OF THE BIOZORB MARKER WITH GENERAL LUMPECTOMY COMPLICATIONS, IT BECOMES EVIDENT THAT SOME OF THE COMPLICATIONS ASSOCIATED WITH BIOZORB MAY STEM FROM THE LUMPECTOMY PROCEDURE ITSELF. BOTH PROCEDURES SHARE OVERLAPPING RISKS, ALTHOUGH THE BIOZORB DEVICE INTRODUCES ADDITIONAL CONSIDERATIONS. HOWEVER, IT HAS BEEN CONFIRMED THAT THE LACK OF DEFINED USER NEEDS AND INADEQUATE TEST METHODS AND TESTING EVIDENCE ARE POTENTIAL ROOT CAUSES FOR THE HARMS REPORTED IN THIS COMPLAINT. THIS CAUSE WILL BE FURTHER INVESTIGATED AND ADDRESSED IN A CAPA. THE RISKS ASSOCIATED WITH THIS COMPLAINT EVENT ARE FURTHER DESCRIBED AND EVALUATED AGAINST THE PRODUCT AND ITS HAZARD ANALYSIS IN THE HEALTH RISK ASSESSMENT BIOZORB COMPLAINT ANALYSIS. UPDATES TO THE BIOZORB HAZARD ANALYSIS RISK FILE WILL BE MONITORED. FUTURE EVENTS WILL BE MONITORED AND TRENDED. COMPLAINT CONFIRMED: NO. DEVICE HISTORY RECORD (DHR) REVIEW: THE DHR WAS REVIEWED WITH THE CORRESPONDING LOT; THE DEVICE WAS RELEASED MEETING ALL QA SPECIFICATIONS.
IT WAS REPORTED THAT ON (B)(6) 2018 A BIOZORB WAS IMPLANTED IN THE PATIENT, AND THE PATIENT REPORTED THAT SUFFERS FROM A HARD, PALPABLE LUMP AT THE SITE OF THE BIOZORB, ALSO REPORTED THAT SUFFERS FROM CONSTANT, SEVERE PAIN, TENDERNESS, SENSITIVITY, AND DISCOMFORT IN THE AREA OF THE DEVICE, PAIN WHEN SLEEPING ON HER LEFT SIDE AND SUFFERS FROM PAIN ANY TIME SHE NEEDS TO MOVE HER HAND AND ARM ABOVE HER SHOULDERS, SEVERELY LIMITING HER MOBILITY. NO ADDITIONAL INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1560129 | BIOZORB | MARKER, RADIOGRAPHIC, IMPLANTABLE | NEU | HOLOGIC, INC | F0221 | H1-180410 | 00851766006061 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Unknown | Other |