FDA Adverse Event
Other
Summary report: N
T-2 IMPLANT
MDR report key: 1425448
·
Received July 29, 2009
Report
- Report Number
- 9610622-2009-00246
- Event Type
- Other
- Date Received
- July 29, 2009
- Date of Event
- July 13, 2009
- Report Date
- July 14, 2009
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- JDS
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INFO ON THIS PER WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS DEPT. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. AS PER THE INFO RECEIVED, THE DEVICES ARE NOT AVAILABLE AT THE TIME OF THE REPORT, DUE TO THE ONGOING LITIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT, THE PT'S REP SENT THE LEGAL DEPT A LETTER OF REPRESENTATION ENCLOSING THE ATTACHED LETTER WHICH WAS SENT TO THE PT FROM (B) (6) HEALTH SERVICES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | T-2 IMPLANT | IMPLANT | JDS | STRYKER OSTEOSYNTHESIS KIEL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |