FDA Adverse Event
Malfunction
Summary report: N
VOLAR SMARTLOCK DISTAL RADIUS PLATE, NARROW, RIGHT
MDR report key: 2481347
·
Received March 5, 2012
Report
- Report Number
- 8010177-2012-00048
- Event Type
- Malfunction
- Date Received
- March 5, 2012
- Date of Event
- December 30, 2011
- Report Date
- February 9, 2012
- 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
DEVICE NOT RETURNED FOR EVAL. INTERNAL INVESTIGATION BASED ON THE AVAILABLE INFO IN PROGRESS.
Description of Event or Problem · 1
ON (B)(6) 2011, A VARIAXDR OPERATION WAS PERFORMED. THE PT WAS ADMITTED TO THE HOSPITAL ON SUSPICION OF RUPTURE OF THE FPL. ON (B)(6) 2012, RECONSTRUCTION OF THE FPL WAS PERFORMED AFTER THE EXTRACTION OF VARIAXDR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VOLAR SMARTLOCK DISTAL RADIUS PLATE, NARROW, RIGHT | IMPLANT | HRS | STRYKER OSTEOSYNTHESIS FREIBURG | NA | LC201SD117 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR |