FDA Adverse Event
Malfunction
Summary report: N
RADIUS SCREW MULTI-A 7.75 X 50MM
MDR report key: 2852141
·
Received November 14, 2012
Report
- Report Number
- 9617544-2012-00500
- Event Type
- Malfunction
- Date Received
- November 14, 2012
- Date of Event
- October 17, 2012
- Report Date
- October 17, 2012
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- KWP
- PMA / PMN Number
- K062270
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "RADIUS SCREW WOULD NOT ACCEPT LOCKING CAP. (IE. NO RESISTANCE FELT UPON FINAL TIGHTENING). DR. (B)(6) REMOVED THE SCREW, WHICH APPEARED TO HAVE A SPLAYED TULIP HEAD, AND REPLACED WITH A DIFFERENT SCREW WHICH ACCEPTED A NEW LOCKING CAP."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RADIUS SCREW MULTI-A 7.75 X 50MM | IMPLANT | KWP | STRYKER SPINE BORDEAUX | NA | R077796 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |