BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-10106

    MDR report key: 2961389 · Received February 11, 2013

    Report

    Report Number
    2520274-2013-10106
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    December 17, 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

    THIS DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. 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 MDR. 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 C5, C6 AND C6, C7 WITH PEDICLE SCREWS AT C5, C6 AND C7. PT HAS BEEN EXPERIENCING PAIN FOR 84 MONTHS. SURGERY DATE WAS (B)(6) 2007 AND POSTOPERATIVELY PT EXPERIENCED CHOKING, REQUIRING OBSERVATION. THIS COMPLAINT IS ON THE RIGHT 16 MM FIXED ANGLE AT C6. THIS IS REPORT 7 OF 7 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59585 KWQ SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1