FDA Adverse Event
Injury
Summary report: N
TROCHANTERIC NAIL KIT, TI GAMMA3® Ø12X170MM X 125°
MDR report key: 4142506
·
Received October 6, 2014
Report
- Report Number
- 0009610622-2014-00538
- Event Type
- Injury
- Date Received
- October 6, 2014
- Date of Event
- September 16, 2014
- Report Date
- September 16, 2014
- Manufacturer
- STRYKER TRAUMA KIEL
- Product Code
- HSB
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
ON (B)(6) 2014, THE PATIENT UNDERWENT THE SURGERY WITH THE G3 NAIL. ON (B)(6) 2014, THE SURGEON CONFIRMED X-RAY THAT THE LAG SCREW HAD SLID. ON (B)(6) 2014, THE LAG SCREW PERFORATED TO THE UPPER PART OF FEMORAL HEAD. THE SURGEON IS PLANNING THE REVISION SURGERY TO A BHA ON (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 624150 | TROCHANTERIC NAIL KIT, TI GAMMA3® Ø12X170MM X 125° | IMPLANT | HSB | STRYKER TRAUMA KIEL | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Required Intervention |