BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVE D CAGE

    MDR report key: 2882235 · Received December 20, 2012

    Report

    Report Number
    3003529816-2012-00010
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 27, 2012
    Manufacturer
    ADVANCED MEDICAL TECHNOLOGIES AG
    Product Code
    MAX
    PMA / PMN Number
    K083626
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PEEK INTERBODY DEVICE WAS BROKEN DURING SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WAVE D CAGE INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX ADVANCED MEDICAL TECHNOLOGIES AG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1