FDA Adverse Event
Injury
Summary report: N
LONG NAIL KIT R2.0, TI, RIGHT 11X380MM X 125
MDR report key: 2132592
·
Received June 10, 2011
Report
- Report Number
- 9610622-2011-00249
- Event Type
- Injury
- Date Received
- June 10, 2011
- Date of Event
- May 27, 2011
- Report Date
- May 30, 2011
- 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
ADDITIONAL INFORMATION HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IMPLANT SURGEON REPORTED TO OUR SALES REP THAT A PATIENT CAME IN WITH PAIN. HE TOOK SOME X-RAYS AND SAW THAT THE NAIL WAS BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LONG NAIL KIT R2.0, TI, RIGHT 11X380MM X 125 | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | K157014 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention |