FDA Adverse Event
Malfunction
Summary report: N
RADIUS CROSS CONNECTOR CLOSER
MDR report key: 2854252
·
Received November 28, 2012
Report
- Report Number
- 9617544-2012-00529
- Event Type
- Malfunction
- Date Received
- November 28, 2012
- Date of Event
- October 30, 2012
- Report Date
- October 30, 2012
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- LXH
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, 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, RESULTS, AND CONCLUSION WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT "WHILE TIGHTENING DOWN ON THE CROSS-CONNECTOR, THE CLAMP BROKE DURING THE PROCEDURE. THE DOCTOR WAS FINAL TIGHTENING WHEN THE METAL CLAMP SNAPPED APART. A BACKUP CROSS-CONNECTOR CLOSER IN THE SET WAS USED TO FINISH THE CASE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RADIUS CROSS CONNECTOR CLOSER | INSTRUMENT | LXH | STRYKER SPINE BORDEAUX | NA | 067692 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |