FDA Adverse Event
Injury
Summary report: N
SUPRACONDYLAR NAIL ?11X240MM
MDR report key: 1284834
·
Received January 9, 2009
Report
- Report Number
- 9610622-2009-00003
- Event Type
- Injury
- Date Received
- January 9, 2009
- Date of Event
- December 1, 2008
- Report Date
- December 8, 2008
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- JDS
- PMA / PMN Number
- K023267
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE PT UNDERWENT SURGERY WITH AO LOCKING PLATE. AFTER SURGERY, THE SURGEON FOUND THROUGH X-RAY THAT THE LOCKING PLATE BROKE. IN 2008, REVISION SURGERY WAS PERFORMED USING T2 SCN. HOWEVER, FOUR MONTHS LATER, THE SURGEON FOUND THROUGH THE X-RAY THAT THE T2 SCN BROKE. THE NAIL WAS BROKEN IN THE FORTH SCREW HOLE FROM DISTAL. EIGHT DAYS LATER, THE SURGEON PERFORMED THE REVISION SURGERY USING THE AO DFN, THE BONE GRAFT AND BONE APATITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUPRACONDYLAR NAIL ?11X240MM | IMPLANT | JDS | STRYKER OSTEOSYNTHESIS KIEL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |