FDA Adverse Event
Injury
Summary report: N
FEMORAL NAIL, A/R 11/340 MM
MDR report key: 1252814
·
Received December 4, 2008
Report
- Report Number
- 9610622-2008-00250
- Event Type
- Injury
- Date Received
- December 4, 2008
- Date of Event
- June 16, 2008
- Report Date
- November 5, 2008
- Manufacturer
- STRYKER OSTEOSYNTHESIS KEIL
- Product Code
- JDS
- PMA / PMN Number
- K032579
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WILL NOT BE RETURNED. NO EVAL WILL BE PERFORMED. IF THE DEVICE OR ADD'L INFO BECOMES AVAILABLE IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IM NAILS BROKE AFTER BEING IMPLANTED FOR 24 MOS. PT WAS REVISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FEMORAL NAIL, A/R 11/340 MM | IMPLANT | JDS | STRYKER OSTEOSYNTHESIS KEIL | NA | 432161 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |