FDA Adverse Event
Injury
Summary report: N
STANDARD COMPRESSION PLATE BROAD HOLES 15 LENGTH 2
MDR report key: 1241587
·
Received November 21, 2008
Report
- Report Number
- 8031020-2008-00204
- Event Type
- Injury
- Date Received
- November 21, 2008
- Date of Event
- June 7, 2008
- Report Date
- November 5, 2008
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- HRS
- PMA / PMN Number
- K012162
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED. NO EVALUATION WILL BE PERFORMED. IF THE DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PLATE BROKE. PATIENT WAS REVISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STANDARD COMPRESSION PLATE BROAD HOLES 15 LENGTH 2 | IMPLANT | HRS | STRYKER OSTEOSYNTHESIS SELZACH | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |