FDA Adverse Event
Injury
Summary report: N
LONG NAIL KIT R2.0, TI, LEFT 11X240MM X 125
MDR report key: 2032701
·
Received March 17, 2011
Report
- Report Number
- 9610622-2011-00116
- Event Type
- Injury
- Date Received
- March 17, 2011
- Date of Event
- February 28, 2011
- Report Date
- March 1, 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
COMPLAINT WAS ENTERED WITH MINIMAL INFO. IT IS NOT KNOWN AT THIS TIME IF THE DEVICE WILL BE RETURNED FOR EVAL. ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
SURGEON REPORTED VIA OUR SALES REP THAT A GAMMA NAIL WHICH HAD BEEN IMPLANTED AT ASKLEPIOS KLINIK WANDSBEK WAS FOUND TO BE BROKEN. THIS PER IS ENTERED ON ONLY MINIMAL INFO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LONG NAIL KIT R2.0, TI, LEFT 11X240MM X 125 | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | K814983 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 95 YR | Required Intervention |