FDA Adverse Event
Injury
Summary report: N
TROCHANTERIC NAIL KIT, TI GAMMA3 10X170MM X 125
MDR report key: 2743257
·
Received September 6, 2012
Report
- Report Number
- 9610622-2012-00385
- Event Type
- Injury
- Date Received
- September 6, 2012
- Date of Event
- April 10, 2008
- Report Date
- August 9, 2012
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- PMA / PMN Number
- K034223
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS DISCARDED. NO EVALUATION WILL BE PERFORMED. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. ADDITIONAL DEVICES: 3060-0080S LAG SCREW, TI GAMMA3 10.5X80MM LOT# K472981; 1896-5035S LOCKING SCREW, FULLY THREADED T2 TIBIA 5X35 MM LOT# K492060.
Description of Event or Problem · 1
ON (B)(6) 2008, G3 OPERATION WAS PERFORMED. THREE DAYS AFTER THE OPERATION, THE PATIENT SUFFERED A FRACTURE AT THE PART OF NAIL'S END. THE PATIENT WAS REVISED TO A LONG NAIL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TROCHANTERIC NAIL KIT, TI GAMMA3 10X170MM X 125 | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | K459484 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Other| R |