FDA Adverse Event
Malfunction
Summary report: N
PALMAR RADIUS FRACTURE PLATE, LOCKING, MEDIUM, LEF
MDR report key: 2013462
·
Received February 3, 2011
Report
- Report Number
- 8010177-2011-00026
- Event Type
- Malfunction
- Date Received
- February 3, 2011
- Date of Event
- December 30, 2010
- Report Date
- January 9, 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 WAS NOT RETURNED FOR EVALUATION. INTERNAL INVESTIGATION IN PROCESS.
Description of Event or Problem · 1
ACCORDING TO THE IMPLANT SURGEON, THIS IS ONE OF THREE PTS WITH A SIMPLE DISTAL RADIUS FRACTURE FOR WHOM THE SURGEON OPERATED WITH MATRIX VOLAR PLATING. AFTER TWO WEEKS CONTROL AND THE PT 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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |