FDA Adverse Event
Injury
Summary report: N
LONG NAIL KIT R2.0, TI, LEFT GAMMA3 ?11X400MM X 13
MDR report key: 2869976
·
Received December 4, 2012
Report
- Report Number
- 9610622-2012-00549
- Event Type
- Injury
- Date Received
- December 4, 2012
- Date of Event
- November 13, 2012
- Report Date
- November 13, 2012
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- PMA / PMN Number
- K034002
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE WILL NOT BE RETURNED. IF THE DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. ADDITIONAL DEVICE 3060-0085S LAG SCREW, TI GAMMA3 - 10.5X85MM LOT# K894800.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT PRESENTED WITH NONUNION SO DOCTOR REMOVED GAMMA AND PROCEEDED TO DIFFERENT NAIL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LONG NAIL KIT R2.0, TI, LEFT GAMMA3 ?11X400MM X 13 | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | K525591 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 91 YR | Other| R |