FDA Adverse Event
Injury
Summary report: N
TROCHANTERIC NAIL
MDR report key: 1161670
·
Received September 15, 2008
Report
- Report Number
- 9610622-2008-00171
- Event Type
- Injury
- Date Received
- September 15, 2008
- Date of Event
- May 13, 2008
- Report Date
- August 26, 2008
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- JDS
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WILL NOT BE RETURNED. NO EVALUATION WILL BE PERFORMED. IF THE DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE NAIL FRACTURED 5 MONTH POST OP. PATIENT REQUIRED REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TROCHANTERIC NAIL | IMPLANT | JDS | STRYKER OSTEOSYNTHESIS KIEL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |