FDA Adverse Event
Other
Summary report: N
STABILIS PLATE TTC
MDR report key: 2428799
·
Received December 29, 2011
Report
- Report Number
- 3004983210-2011-00012
- Event Type
- Other
- Date Received
- December 29, 2011
- Date of Event
- August 24, 2011
- Report Date
- December 13, 2011
- Manufacturer
- TORNIER INC.
- Product Code
- HRS
- PMA / PMN Number
- K090139
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
THIS IS THE FINAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE. NO ADDITIONAL INFORMATION IS ANTICIPATED.
Description of Event or Problem · 1
ON (B)(6) 2011, PT WAS ADMITTED TO THE HOSPITAL TO UNDERGO A MULTISTAGE FIXATION SALVAGE PROCEDURE FOR HER LEFT ANKLE AFTER A FAILED TTC FUSION DUE TO INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STABILIS PLATE TTC | NONE | HRS | TORNIER INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR |