FDA Adverse Event
Malfunction
Summary report: N
4 HOLE PIN CLAMP, BLUE MONOTUBE TRIAX ? 20MM
MDR report key: 1190574
·
Received October 2, 2008
Report
- Report Number
- 8031020-2008-00086
- Event Type
- Malfunction
- Date Received
- October 2, 2008
- Date of Event
- September 3, 2008
- Report Date
- September 5, 2008
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- HTY
- PMA / PMN Number
- K861766
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED. NO EVALUATION WILL BE PERFORMED. IF THE DEVICE OR ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "SURGEON PUT ON A PIN CLAMP BUT WOULD NOT TIGHTEN AGAINST THE CARBON ROD. IT WAS AS IF THE BOLT WAS STIPPED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4 HOLE PIN CLAMP, BLUE MONOTUBE TRIAX ? 20MM | IMPLANT | HTY | STRYKER OSTEOSYNTHESIS SELZACH | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Other |