FDA Adverse Event
Malfunction
Summary report: N
PALMAR RADIUS FRACTURE PLATE, LOCKING, MEDIUM, LEF
MDR report key: 2020617
·
Received February 10, 2011
Report
- Report Number
- 8010177-2011-00041
- Event Type
- Malfunction
- Date Received
- February 10, 2011
- Date of Event
- November 24, 2010
- Report Date
- January 18, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS FREIBURG
- Product Code
- HRS
- PMA / PMN Number
- K040022
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE IS NOT AVAILABLE FOR EVALUATION. INTERNAL INVESTIGATION IN PROCESS BUT NOT YET COMPLETE.
Description of Event or Problem · 1
ACCORDING TO THE IMPLANT SURGEON, THIS ONE OF THREE PATIENTS WITH SIMPLE DISTAL RADIUS FRACTURE FOR WHOM THE SURGEON OPERATED WITH MATRIX VOLAR PLATING. AFTER TWO WEEKS CONTROL AND THE PATIENT STILL IN A CAST, THE X-RAY SHOWS THAT THE PLATE BEGINS TO BEND/CRACK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PALMAR RADIUS FRACTURE PLATE, LOCKING, MEDIUM, LEF | IMPLANT | HRS | STRYKER OSTEOSYNTHESIS FREIBURG | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |