NUROLON NYLON SUTURE UNKNOWN PRODUCT
Report
- Report Number
- 2210968-2023-03432
- Event Type
- Injury
- Date Received
- May 9, 2023
- Date of Event
- November 18, 2020
- Report Date
- May 9, 2023
- Manufacturer
- ETHICON INC.
- Product Code
- GAR
- PMA / PMN Number
- K946173
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL INFORMATION: RELATED - CONCOMITANT PRODUCTS.
(B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2023-03428, 2210968-2023-03429, 2210968-2023-03430, 2210968-2023-03431, 2210968-2023-03433, 2210968-2023-03434. CITATION: WORLD NEUROSURG. (2021) 146:E1103-E1117; HTTPS://DOI.ORG/10.1016/J.WNEU.2020.11.102.
TITLE: THE 270 CIRCUMFERENTIAL MICROSURGICAL DECOMPRESSION OF THE FORAMEN MAGNUM IN ADULT CHIARI MALFORMATION TYPE I: SINGLE SURGEON SERIES OF 130 PATIENTS WITH SYRINGOMYELIA, NEUROLOGIC, AND HEADACHE OUTCOMES TO FURTHER IMPROVE POSTOPERATIVE OUTCOMES, WE PROSPECTIVELY ADOPTED A MODIFICATION OF ADULT CM-I OPERATIVE TREATMENT BY USING A CIRCUMFERENTIAL DECOMPRESSION OF THE FORAMEN MAGNUM OF 270 DEGREES. WE PRESENT OUR EXPERIENCES WITH THIS SURGICAL MODIFICATION IN A SERIES OF PATIENTS. FROM (B)(6) 2003 TO (B)(6) 2018, 130 PATIENTS WITH CHIARI MALFORMATION TYPE I WERE INCLUDED IN THE STUDY. THERE WERE 18 MALES (MEAN AGE 39+/-14 YEARS) AND 112 FEMALES (MEAN AGE 37 +/- 12 YEARS). THE OPERATION CONSISTED OF A 270 DEGREES IRCUMFERENTIAL MICROSURGICAL DECOMPRESSION OF THE FORAMEN MAGNUM AND OPENING OF THE DURA AND ARACHNOID MEMBRANE, FOLLOWED BY MICROSURGICAL DECOMPRESSION, AND OPENING OF THE FORAMINA OF MAGENDIE AND LUSCHKA AND THE BILATERAL CEREBELLOMEDULLARY CISTERNS. DURING THE PROCEDURE, BLEEDING IS EASILY CONTROLLED WITH A COMPETITOR GELFOAM POWDER (MANUFACTURER: PFIZER) AND THE DURA IS OPENED IN THE SHAPE OF THE LETTER Y AND TACKED TO SURROUNDING SOFT TISSUES WITH 4-0 NUROLON STITCHES (ETHICON). CLOSURE IS PERFORMED WITH A TRIANGULAR PIECE OF BOVINE PERICARDIUM ALLOGRAFT (MANUFACTURER: MEDTRONIC) PRECUT TO FIT THE ALLOTTED SPACE USING 4-0 NUROLON (ETHICON) RUNNING AND SINGLE SUTURES. THE PREVIOUSLY HARVESTED ABDOMINAL FAT IS PLACED CAUTIOUSLY ON TOP OF THE DURA ALONG WITH NON-ETHICON FIBRIN GLUE (MANUFACTURER: UNKNOWN) TO ELIMINATE THE DEAD SPACE CREATED BY BONE REMOVAL AND TO PREVENT CSF LEAK OR PSEUDOMENINGOCELE FORMATION. FOLLOW-UP OCCURS 3 WEEKS POSTOPERATIVELY FOR SUTURE REMOVAL. SUBSEQUENTLY, THE PATIENT IS SEEN 3 MONTHS LATER FOR MRI STUDY, THEN IN 9 MONTHS, AND SUBSEQUENTLY ON A YEARLY BASIS, INCLUDING CLINICAL AND NEURORADIOLOGIC EXAMINATIONS PROTOCOLS. THE REPORTED COMPLICATIONS INCLUDED CASE 4, A MALE WITH PSEUDOMENINGOCELE/CSF LEAK AFTER SURGERY (N=1), CASE 5, A FEMALE WITH PSEUDOMENINGOCELE/CSF LEAK AFTER SURGERY (N=1), CASE 6, A FEMALE WITH PSEUDOMENINGOCELE/CSF LEAK AFTER SURGERY (N=1), CASE 76, A FEMALE WITH SUPERFICIAL WOUND INFECTION (N=1), CASE 96, A FEMALE WITH SUPERFICIAL WOUND INFECTION (N=1), CASE 119, A FEMALE WITH SUPERFICIAL WOUND INFECTION (N=1) AND A FEMALE WITH SUPERFICIAL WOUND INFECTION (N=1). IN CONCLUSION, OUR MODIFIED 270 DEGREES CIRCUMFERENTIAL MICROSURGICAL FORAMEN MAGNUM DECOMPRESSION FOR ADULT CM-I APPEARS TO BE BENEFICIAL IN IMPROVEMENT OF OUTCOMES, NAMELY IN RESOLUTION OF THE SYRINX, NEUROLOGIC SYMPTOMS, AND HEADACHES. WE ALSO CONFIRM THE ASSOCIATION OF BODY MASS INDEX WITH CM-I. FURTHER STUDIES ARE NEEDED TO CONFIRM OUR RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1841047 | NUROLON NYLON SUTURE UNKNOWN PRODUCT | SUTURE, NONABSORBABLE, SYNTHETIC | GAR | ETHICON INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention | BOVINE PERICARDIUM ALLOGRAFT, MEDTRONIC| FIBRIN GLUE, UNKNOWN MFG| GELFOAM POWDER, PFIZER |