FDA Adverse Event
Injury
Summary report: N
FEMORAL NAIL, A/R, R1500 9X300MM
MDR report key: 1211123
·
Received October 23, 2008
Report
- Report Number
- 9610622-2008-00201
- Event Type
- Injury
- Date Received
- October 23, 2008
- Date of Event
- September 28, 2008
- Report Date
- September 28, 2008
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- JDS
- PMA / PMN Number
- K081152
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED, IN 2007, THE PATIENT UNDERWENT THE SURGERY WITH THE T2 FEMORAL NAIL (PLACED BY THE RETROGRADE). AFTER THE SURGERY, THE SURGEON FOUND ON AN X-RAY THAT THE NAIL WAS BROKEN AT THE SCREW HOLE. THE PATIENT BONE WAS PSEUDOARTHROSIS (NON UNION). THE SURGEON USED ANOTHER NAIL IN THE REVISION SURGERY AND THE SURGERY WAS COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FEMORAL NAIL, A/R, R1500 9X300MM | IMPLANT | JDS | STRYKER OSTEOSYNTHESIS KIEL | NA | K940520 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Required Intervention |