FDA Adverse Event
Malfunction
Summary report: N
THOR STANDARD SCREW 6.0X31MM
MDR report key: 2770207
·
Received October 1, 2012
Report
- Report Number
- 9617544-2012-00417
- Event Type
- Malfunction
- Date Received
- October 1, 2012
- Date of Event
- September 3, 2012
- Report Date
- September 3, 2012
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- KWP
- PMA / PMN Number
- K073437
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION. THE OTHER THOR SCREW REFERENCED IN THE EVENT DESCRIPTION WAS REPORTED WITH REPORT # 9617544-2012-00416.
Description of Event or Problem · 1
IT WAS REPORTED THAT "THE PATIENT HAD "THOR" IMPLANTED FOR A L5-S1 ALIF. MONTHS PAST THE SURGERY THE S1 SCREWS BROKE. THE PATIENT IS FUSED AND IS NOT EXPERIENCING ANY PAIN OR DISCOMFORT FROM THE INCIDENT. SURGEON MOST LIKELY WILL NOT TAKE OUT THE PLATE OR THE SCREWS. S1 SCREWS BROKE: 2, (B)(4) 6.0 X 31 STANDARD SCREWS".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THOR STANDARD SCREW 6.0X31MM | IMPLANT | KWP | STRYKER SPINE BORDEAUX | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |