ECD H24-33 PEEK
Received Jan 17, 2014 · Event occurred Dec 18, 2013
Report 8030965-2014-00034 · MDR key 3581220
Device
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN IMPLANT. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. A REVIEW OF DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND DURING MANUFACTURING THAT WOULD CONTRIBUTE TO THIS COMPLAINT. PLACEHOLDER.
Description of Event or Problem
DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6); THAT DURING THE SURGERY ON (B)(6) 2013 THAT UPON INSERTION OF THE EXPANDABLE CORPECTOMY DEVICE INTRAOPERATIVELY, THE DEVICE WOULD NOT EXPAND. THE THREADS ON THE MECHANISM OF THE DEVICE WERE WORN AND THEREFORE THE DISTRACTOR WAS UNABLE TO OPEN UP THE DEVICE. THE WHEEL ON THE DISTRACTOR HAD FLATTENED THE TEETH ON THE DEVICE. THE SURGERY TIME WAS EXTENDED 30 MINS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).