FDA Adverse Event
Injury
Summary report: N
LONG NAIL KIT R2.0, TI, RIGHT ?11X320MM X 130?
MDR report key: 1032848
·
Received April 22, 2008
Report
- Report Number
- 9610622-2008-00047
- Event Type
- Injury
- Date Received
- April 22, 2008
- Date of Event
- March 21, 2008
- Report Date
- April 2, 2008
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- PMA / PMN Number
- K034002
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUPPLIED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT PRESENTED WITH PAIN IN THEIR HIP, WHEN WALKING AND ON X-RAY, IT WAS DISCOVERED THAT THE NAIL HAD FRACTURED. IT IS FURTHER REPORTED THAT THE PT WAS REVISED SIXTEEN MONTHS POST PRIMARY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LONG NAIL KIT R2.0, TI, RIGHT ?11X320MM X 130? | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | K790522 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |