FDA Adverse Event
Injury
Summary report: N
BOS PLATE
MDR report key: 1130469
·
Received August 20, 2008
Report
- Report Number
- 8031020-2008-00068
- Event Type
- Injury
- Date Received
- August 20, 2008
- Date of Event
- July 14, 2008
- Report Date
- July 18, 2008
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- HRS
- PMA / PMN Number
- K972323
- 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 AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IN 2008, THE PT UNDERWENT THE SURGERY WITH BOS SMALL BONE PLATE AND SCREWS. ONE MONTH AFTER THE SURGERY, THE SURGEON FOUND THROUGH X-RAY THAT THE SMALL BONE PLATE WAS BROKEN. AT APPROX 36 DAYS POST-PROCEDURE, THE SURGEON USED NARROW SMALL BONE PLATE (6 HOLE) IN THE REVISION SURGERY AND THE SURGERY WAS COMPLETED WITHOUT PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BOS PLATE | IMPLANT | HRS | STRYKER OSTEOSYNTHESIS SELZACH | UNK | K04087 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Required Intervention |