FDA Adverse Event
Malfunction
Summary report: N
VOLAR SMARTLOCK DISTAL RADIUS PLATE, STANDARD, LEF
MDR report key: 1864626
·
Received October 7, 2010
Report
- Report Number
- 8010177-2010-00371
- Event Type
- Malfunction
- Date Received
- October 7, 2010
- Date of Event
- September 6, 2010
- Report Date
- September 10, 2010
- Manufacturer
- STRYKER OSTEOSYNTHESIS FREIBURG
- Product Code
- HRS
- PMA / PMN Number
- K040022
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IN PROCESS, BUT NOT YET COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VARIAX DR PLATE WAS USED FOR THE FRACTURE OF THE DISTAL RADIUS ON (B)(6) 2010. THE PLATE WAS TRANSFORMED AND THE DISTAL RADIUS REFRACTURED WHEN THE PT FELL ON THE BATHROOM FLOOR ON (B)(6) 2010. ON (B)(6) 2010 VARIAX LONG PLATE WAS USED FOR THE REFRACTURE. NOW, THE PT IS UNDER OBSERVATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VOLAR SMARTLOCK DISTAL RADIUS PLATE, STANDARD, LEF | IMPLANT | HRS | STRYKER OSTEOSYNTHESIS FREIBURG | NA | L1N01S8294 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR |