FDA Adverse Event
Injury
Summary report: N
LOCKING NAIL 12X169 MM X130
MDR report key: 2062564
·
Received April 7, 2011
Report
- Report Number
- 9610622-2011-00151
- Event Type
- Injury
- Date Received
- April 7, 2011
- Date of Event
- June 1, 2010
- Report Date
- March 14, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. THIS DEVICE IS NOT CLEARED FOR SALE IN THE UNITED STATES, BUT A SIMILAR DEVICE IS.
Description of Event or Problem · 1
IN 2001, THE PT UNDERWENT THE SURGERY WITH THE GAMMA AP-J NAIL. IN 2007, THE SURGEON FOUND THROUGH THE X-RAY THAT THE NAIL WAS BROKEN IN THE PART OF LAG SCREW HOLE. THE FRACTURE PART OF PT WAS A NON UNION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LOCKING NAIL 12X169 MM X130 | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | K441353 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |