2.4MMX10MM HT X-DR SCREW 5PK
Report
- Report Number
- 0001032347-2023-00452
- Event Type
- Injury
- Date Received
- December 5, 2023
- Date of Event
- April 24, 2016
- Report Date
- April 23, 2024
- Manufacturer
- BIOMET MICROFIXATION
- Product Code
- HWC
- PMA / PMN Number
- K001238
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, AR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
D10 ¿ MEDICAL PRODUCTS: ITEM# 85-2410, LOT# NI, 2.4MMX10MM HT X-DR SCREW 5PK - QTY (B)(40 SCREWS. ITEM# 24-1060, LOT# NI, FRACTURE 16 HOLE QTY (B)(4). NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, LOT IDENTIFICATION WAS NOT PROVIDED. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: THE PATIENT HAD A MEDICAL HISTORY INCLUDING OSSIFYING FIBROMA ILLNESS. THE PLATE WAS REMOVED DUE TO NECROSIS OF THE ILIAC CREST WITH AUTOGENOUS BONE GRAFT. NO INTRA-OPERATIVE COMPLICATIONS OR EVENTS. THE MEDICAL RECORDS WERE POOR QUALITY WITH PARTIALLY LEGIBLE HANDWRITING. AN IMAGE WAS ASSESSED BUT NOT SENT FOR RADIOLOGIST REVIEW AS THE IMAGE DATE IS NOT PROVIDED AND THE IMAGE IS OF POOR QUALITY. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IT WAS REPORTED THERE WAS A SURGICAL SITE INFECTION WITH BONE GRAFT FAILURE DUE TO NECROSIS AND A CONTRIBUTING FACTOR OF THE ISSUE WAS OSSIFYING FIBROMA/ILLNESS, HOWEVER, THIS COULD NOT BE CONFIRMED WITHOUT COMPLETE LEGIBLE MEDICAL RECORDS. THE REPORTED EVENT IS UNCONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
THIS REPORT IS BEING SUBMITTED TO UPDATE ADDITIONAL INFORMATION. INITIAL MEDWATCH WAS SUBMITTED WITH A NOTIFICATION DATE OF NOVEMBER 7, 2023, AND SUBMITTED ON DECEMBER 5, 2023; HOWEVER, THE CORRECT NOTIFICATION DATE IS SEPTEMBER 17, 2023. G3 WAS CORRECTED IN PREVIOUS MEDWATCH (0001032347-2023-00452-2).
THIS REPORT IS BEING SUBMITTED TO UPDATE ADDITIONAL INFORMATION IN SECTIONS B4, B5, E1, E2, E3, G3, G6, H2, H6, AND H10.
ZIMMER BIOMET COMPLAINT (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
IT WAS REPORTED THAT THE PATIENT WAS REVISED AS THERE WAS A SURGICAL SITE INFECTION WITH BONE GRAFT FAILURE DUE TO NECROSIS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT THE PATIENT WAS REVISED AS THERE WAS A SURGICAL SITE INFECTION WITH BONE GRAFT FAILURE DUE TO NECROSIS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1963075 | 2.4MMX10MM HT X-DR SCREW 5PK | SCREW, FIXATION, BONE | HWC | BIOMET MICROFIXATION | N/A | UNK | |
| 2064489 | 2.4MMX10MM HT X-DR SCREW 5PK | SCREW, FIXATION, BONE | HWC | BIOMET MICROFIXATION | N/A | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Male | Required Intervention| H |