BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KWQ

    MDR report key: 3015130 · Received February 27, 2013

    Report

    Report Number
    2520274-2013-10158
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Report Date
    March 28, 2011
    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 FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. NO SAMPLE WAS RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED. NO CONCLUSION COULD BE DRAWN, AS SAMPLE WAS NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT PARTICIPATED IN A MULTI-CENTER, 4-ARM STUDY AT VERTEBRAL LEVELS 1, 2, 3 OR 4 TO EVALUATE THE CLINICAL AND RADIOGRAPHIC OUTCOMES IN PATIENTS DIAGNOSED WITH CERVICAL DEGENERATIVE DISEASE (DDD) BETWEEN C2-C7. PATIENT WAS IMPLANTED WITH A VECTRA-T CERVICAL PLATE AND AN ADVANCED ACF SPACER AT LEVELS C3 C4, C4 C5, C5 C6 AND C6 C7 WITH PEDICLE SCREWS AT C3, C4, C5, C6 AND C7. THE PATIENT EXPERIENCED PAIN FOR 60 MONTHS. SURGERY DATE WAS (B)(6) 2007 AND POSTOPERATIVE PATIENT EXPERIENCED NUMBNESS, REQUIRING NO TREATMENT. THIS IS 8 OF 11 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84660 KWQ KWQ SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1