FDA Adverse Event
Injury
Summary report: N
LONG NAIL KIT R2.0, TI, LEFT GAMMA3 ?11X380MM X 12
MDR report key: 2832993
·
Received October 30, 2012
Report
- Report Number
- 9610622-2012-00486
- Event Type
- Injury
- Date Received
- October 30, 2012
- Date of Event
- October 10, 2012
- Report Date
- October 16, 2012
- Manufacturer
- STRYKER TRAUMA GMBH
- 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 ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ADD'L DEVICES 3060-0100S LAG SCREW, TI GAMMA3 10.5X100MM LOT # K263853.
Description of Event or Problem · 1
IMPLANT SURGEON REPORTED TO OUR SALES REP THAT A PT CAME IN WITH PAIN. X-RAYS WERE TAKEN AND IT WAS OBSERVED THAT THE NAIL IS BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LONG NAIL KIT R2.0, TI, LEFT GAMMA3 ?11X380MM X 12 | IMPLANT | HSB | STRYKER TRAUMA GMBH | NA | K911248 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Other| R |