FDA Adverse Event
Other
Summary report: N
PALMAR RADIUS FRACTURE PLATE, LOCKING, MEDIUM, LON
MDR report key: 1120769
·
Received August 15, 2008
Report
- Report Number
- 8010177-2008-00052
- Event Type
- Other
- Date Received
- August 15, 2008
- Date of Event
- July 16, 2008
- Report Date
- August 15, 2008
- Manufacturer
- STRYKER OSTEOSYNTHESIS FREIBURG
- Product Code
- HRS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON (B) (6) 2008, THE PT UNDERWENT THE SURGERY WITH MATRIX SMART LOCK PLATE AND SCREWS. TWO MOS AFTER THE SURGERY, THE SURGEON FOUND THROUGH THE X-RAY THAT THE DISTAL LOCKING SCREW WAS BROKEN. THE SURGEON USED SMART LOCK PLATE IN THE REVISION SURGERY AND THE SURGERY WAS COMPLETED WITHOUT PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PALMAR RADIUS FRACTURE PLATE, LOCKING, MEDIUM, LON | IMPLANT | HRS | STRYKER OSTEOSYNTHESIS FREIBURG | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |