NONE
Received Feb 11, 2013
Report 2520274-2013-10055 · MDR key 2961320
Device
Generic name
None
Manufacturer
Synthes (usa)Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- Pain
Narrative
Description of Event or Problem
PT PARTICIPATED IN A MULTI-CENTER, 4-ARM STUDY AT VERTEBRAL LEVELS 1, 2, 3, OR 4 TO EVALUATE THE CLINICAL AND RADIOGRAPHIC OUTCOMES IN PTS DIAGNOSED WITH CERVICAL DEGENERATIVE DISC DISEASE (DDD) BETWEEN C2 - C7. PREOPERATIVE DIAGNOSIS WAS SYMPTOMS OF RADICULOPATHY. PT WAS IMPLANTED WITH A VECTRA-T CERVICAL PLATE AND A CC ACF SPACER AT LEVELS C3 C4, C4 C5, C5 C6, C6 C7 WITH PEDICLE SCREWS AT C3, C4, C5, C6, AND C7. PT HAD BEEN EXPERIENCING PAIN FOR 1 MONTH. SURGERY DATE WAS (B)(6) 2007 AND POSTOPERATIVELY, PT EXPERIENCED WEAKNESS IN FINGERS, REQUIRING PT. THIS IS REPORT 8 OF 11 FOR THIS EVENT.
Additional Manufacturer Narrative
DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADD'L INFO RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL REPORT. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.