FDA Adverse Event
Other
Summary report: N
TORNIER
MDR report key: 2522749
·
Received June 25, 2010
Report
- Report Number
- 3004983210-2010-00005
- Event Type
- Other
- Date Received
- June 25, 2010
- Report Date
- June 25, 2010
- Manufacturer
- TORNIER INC.
- Product Code
- HRS
- PMA / PMN Number
- 053408
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT IS REPORTED THAT BONE FUSION PLATE DEVICES HAD BEEN IMPLANTED IN BOTH FEET, ONE EACH, OF A PATIENT AND BOTH PLATES BROKE WHEN PATIENT WAS PERMITTED TO WALK. BOTH PLATES ARE REPORTED AS EXPLANTED IN REVISION SURGERY. BOTH EXPLANTED DEVICES HAVE BEEN RETURNED TO PERMIT ENGINEERING EVALUATION. CLINICAL DATA HAS BEEN REQUESTED - BUT NOT RECEIVED. DATES OF IMPLANT/EXPLANT SURGERY HAVE BEEN REQUESTED BUT HAVE NOT BEEN REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TORNIER | PLATE, FIXATION, BONE | HRS | TORNIER INC. | 0207 & 1108 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |