FDA Adverse Event
Injury
Summary report: N
SUPRACONDYLAR NAIL ?10X200MM
MDR report key: 1260673
·
Received December 9, 2008
Report
- Report Number
- 9610622-2008-00259
- Event Type
- Injury
- Date Received
- December 9, 2008
- Date of Event
- November 8, 2008
- Report Date
- November 13, 2008
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- PMA / PMN Number
- K023267
- 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 2008, THE PATIENT UNDERWENT THE SURGERY WITH THE T2 SCN. SIX MONTHS LATER, THE PATIENT HAD THE PAIN IN THE FEMORAL BONE. WHEN THE PATIENT TWISTED HIS FOOT, THERE WAS PAIN AND THE PATIENT VISITED THE HOSPITAL. THE SURGEON FOUND THROUGH THE X-RAY THAT THE NAIL BROKE AROUND THE PROXIMAL LOCKING SCREW HOLE. THE SAME MONTH, THE REVISION SURGERY WAS PERFORMED. DURING THE REVISION SURGERY, THE SCN WAS EXTRACTED AND LONG SCN WAS USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUPRACONDYLAR NAIL ?10X200MM | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | K726341 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention |