FDA Adverse Event
Injury
Summary report: N
SUPRACONDYLAR NAIL 12X170MM
MDR report key: 1420299
·
Received July 22, 2009
Report
- Report Number
- 9610622-2009-00228
- Event Type
- Injury
- Date Received
- July 22, 2009
- Date of Event
- May 19, 2009
- Report Date
- June 26, 2009
- 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 INFORMATION HAS BEEN REQUESTED, AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IN 2008, THE PATIENT UNDERWENT THE SURGERY WITH THE T2 SCN. IN 2009, THE PATIENT UNDERWENT THE REMOVING SURGERY OF THE SCN NAIL AND SCREWS. AFTERWARDS, THE SURGEON FOUND THROUGH THE X-RAY THAT THE FOREIGN MATERIAL AROUND THE PATIENT BONE. THUS THE PATIENT UNDERWENT THE REMOVING SURGERY OF THE FOREIGN MATERIAL AT APPROXIMATELY 5 WEEKS LATER. THE SURGEON FOUND THAT THE FOREIGN MATERIAL IS METAL SHREDS. HOWEVER, THE SURGEON WAS NOT ABLE TO REMOVE A PART OF METAL SHREDS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUPRACONDYLAR NAIL 12X170MM | IMPLANT | JDS | STRYKER OSTEOSYNTHESIS KIEL | NA | K982291 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |