BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZAVATION

    MDR report key: 5289220 · Received December 11, 2015

    Report

    Report Number
    3008583793-2015-00003
    Event Type
    Malfunction
    Date Received
    December 11, 2015
    Manufacturer
    ZAVATION
    Product Code
    KWQ
    PMA / PMN Number
    K112533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SCREW BACKED OUT POSTOPERATIVELY DUE TO FAILURE OF A 4-LEVEL CERVICAL PLATE LOCKING MECHANISM. THE PATIENT UNDERWENT REVISION SURGERY WITH NO FURTHER POST OPERATIVE COMPLICATIONS REPORTED. NOTE: LIMITED DETAILS RECEIVED, FAILED IMPLANT HAS BEEN RETURNED AND WILL BE EVALUATED TO DETERMINE NATURE / CAUSE OF FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820016 ZAVATION CERVICAL PLATE - 4 LEVEL KWQ ZAVATION 30-0468 Z0873

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention