FDA Adverse Event
Injury
Summary report: N
STANDARD COMPRESSION PLATE BROAD
MDR report key: 1020646
·
Received March 27, 2008
Report
- Report Number
- 8031020-2008-00012
- Event Type
- Injury
- Date Received
- March 27, 2008
- Date of Event
- January 24, 2008
- Report Date
- February 29, 2008
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- HRS
- PMA / PMN Number
- K012162
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- 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
THE PLATE WAS BROKEN IN PATIENT'S THIGH BONE AFTER OPERATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STANDARD COMPRESSION PLATE BROAD | IMPLANT | HRS | STRYKER OSTEOSYNTHESIS SELZACH | AN | K10145 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |