FDA Adverse Event
Other
Summary report: N
VOLAR SMARTLOCK DISTAL RADIUS PLATE, NARROW, LEFT
MDR report key: 2111058
·
Received May 20, 2011
Report
- Report Number
- 8010177-2011-00143
- Event Type
- Other
- Date Received
- May 20, 2011
- Date of Event
- April 29, 2011
- Report Date
- April 29, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS FREIBURG
- Product Code
- HRS
- PMA / PMN Number
- K040022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED; THEREFORE, THE INCIDENT COULD NOT BE CONFIRMED. IT COULD ONLY BE ASSUMED THAT THE ROOT CAUSE IS MOST LIKELY ATTRIBUTED TO AN OVERLOAD THAT CAUSED THE POSTOPERATIVE BENDING OF THE PLATE. NO FURTHER INVESTIGATIONS COULD HAVE BEEN CONDUCTED BECAUSE NEITHER THE PLATE, X-RAYS, NOR ANY LOT # WAS SUBMITTED.
Description of Event or Problem · 1
"PT FELL AND THE PLATE BENT UPON FALL SO REVISION WAS REQUIRED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VOLAR SMARTLOCK DISTAL RADIUS PLATE, NARROW, LEFT | IMPLANT | HRS | STRYKER OSTEOSYNTHESIS FREIBURG | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |