FDA Adverse Event
Injury
Summary report: N
TROCHANTERIC NAIL KIT
MDR report key: 1071427
·
Received July 8, 2008
Report
- Report Number
- 9610622-2008-00105
- Event Type
- Injury
- Date Received
- July 8, 2008
- Date of Event
- April 14, 2008
- Report Date
- June 13, 2008
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- JDS
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED. NO EVALUATION WILL BE PERFORMED. IF ADDITIONAL INFORMATION OR DEVICE BECOMES AVAILABLE, IT BE REPORTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED BY PATIENT'S ATTORNEY THAT HIS CLIENT WAS TREATED WITH A GAMMA NAIL AT THE LEFT FEMUR IN 2006. DUE TO THE NAIL FRACTURING A REVISION SURGERY BECAME NECESSARY IN 2008.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TROCHANTERIC NAIL KIT | IMPLANT | JDS | STRYKER OSTEOSYNTHESIS KIEL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |