FDA Adverse Event Malfunction Summary report: N

2520274-2013-10054

MDR report key: 2961336 · Received February 11, 2013

Report

Report Number: 2520274-2013-10054
Event Type: Malfunction
Date Received: February 11, 2013
Report Date: December 29, 2007
Manufacturer: SYNTHES (USA)
Product Code: KWQ
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED (B)(4) 2012. 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.

Description of Event or Problem · 1

PT PARTICIPATED IN A (B)(4) 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 COMPLAINT IS ON THE RIGHT 14 MM FIXED ANGLE SCREW AT C5. THIS IS REPORT 7 OF 11 FOR THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
60200			KWQ	SYNTHES (USA)

Patients

Seq	Age	Sex	Outcome	Treatment
1