FDA Adverse Event
Injury
Summary report: N
LONG NAIL KIT R2.0, TI, LEFT GAMMA3 11X360MM X 12
MDR report key: 2910741
·
Received January 8, 2013
Report
- Report Number
- 9610622-2013-90012
- Event Type
- Injury
- Date Received
- January 8, 2013
- Date of Event
- December 3, 2012
- Report Date
- December 18, 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
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE (B)(6) PHYSICIAN OF THE HOSPITAL, REPORTED TO OUR SALES REP THAT A PATIENT CAME IN WITH PAIN. AN XRAY WAS TAKEN AND IT APPEARS THAT THE G3 NAIL WAS BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 8721 | LONG NAIL KIT R2.0, TI, LEFT GAMMA3 11X360MM X 12 | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | K911249 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other| R |