BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURVED 9MM WEDGED VBR DEVICE, 5 DEGREES

    MDR report key: 1693770 · Received May 10, 2010

    Report

    Report Number
    1526439-2010-00065
    Event Type
    Malfunction
    Date Received
    May 10, 2010
    Date of Event
    March 2, 2010
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    MQP
    PMA / PMN Number
    K031635
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY SPINE IS AWAITING THE RETURN OF THE BROKEN FRAGMENT THAT WAS REMOVED FROM THE SURGICAL SITE. A FOLLOW UP REPORT WILL BE SUBMITTED UPON RECEIPT OF THE DEVICE FRAGMENT AND COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT A SECTION OF THE SPINAL CAGE BROKE OFF OF THE DEVICE DURING INSERTION. THE SMALLER BROKEN PORTION WAS REMOVED FROM THE SURGICAL SITE AND THE MAJOR PORTION OF THE CAGE WAS IMPLANTED. THE INTERNATIONAL AFFILIATE WAS AWARE OF THIS EVENT ON (B)(6), 2010. HOWEVER, THE EVENT WAS NOT REPORTED TO DEPUY SPINE UNTIL (B)(6), 2010. THE AFFILIATE HAS BEEN REMINDED OF THE NEED TO IMMEDIATELY REPORT ADVERSE INCIDENTS. AS A COMPROMISED DEVICE HAS BEEN IMPLANTED, A MEDWATCH REPORT IS BEING SUBMITTED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURVED 9MM WEDGED VBR DEVICE, 5 DEGREES SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK