FDA Adverse Event
Injury
Summary report: N
UNKNOWN GAMMA3 LAG SCREW
MDR report key: 2850815
·
Received November 21, 2012
Report
- Report Number
- 9610622-2012-00541
- Event Type
- Injury
- Date Received
- November 21, 2012
- Date of Event
- March 1, 2011
- Report Date
- November 14, 2012
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HWC
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE WILL NOT BE RETURNED. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THIS CASE WAS PRESENTED AT THE MEETING OF (B)(6) ON (B)(6) 2012. THE SURGEON USED THE G3 NAILS (292 CASE) FROM (B)(6) 2005 TO (B)(6) 2011. THE ONE OF 292 CASES, THE PATIENT FELT THE PAIN BY OVER TELESCOPING OF THE LAG SCREW. THEREFORE THE REVISION SURGERY WAS PERFORMED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN GAMMA3 LAG SCREW | IMPLANT | HWC | STRYKER OSTEOSYNTHESIS KIEL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other| R |