FDA Adverse Event
Injury
Summary report: N
LAG SCREW, TI GAMMA3 10.5X95MM
MDR report key: 2824465
·
Received October 25, 2012
Report
- Report Number
- 9610622-2012-00482
- Event Type
- Injury
- Date Received
- October 25, 2012
- Date of Event
- October 9, 2012
- Report Date
- October 9, 2012
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- PMA / PMN Number
- K032244
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THE DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. ADDITIONAL DEVICE: 3130-1180S TROCHANTERIC NAIL KIT, TI GAMMA3, 11X180MM X 130, LOT NO. K189059, 1896-5035S, LOCKING SCREW, FULLY THREADED T2 TIBIA, 5X35 MM LOT NO. K239457.
Description of Event or Problem · 1
IT WAS REPORTED THAT, DUE TO LAG SCREW CUTTING OUT OF THE FEMORAL HEAD, THE IMPLANTS LISTED ABOVE WERE REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAG SCREW, TI GAMMA3 10.5X95MM | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | K257945 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |