BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 4336531 · Received December 17, 2014

    Report

    Report Number
    1030489-2014-04759
    Event Type
    Injury
    Date Received
    December 17, 2014
    Date of Event
    November 21, 2014
    Report Date
    November 21, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 6950315, 510K # K042498 WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR CERVICAL FUSION AT THE OCCIPITAL TO T2. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY TO IRRIGATE AND REMOVE PART OF THE CONSTRUCT DUE TO A SUSPECTED INFECTION ASSOCIATED WITH FISTULA GENERATED ON THE OCCIPITAL BONE. INTRAOPERATIVELY IT WAS FOUND THAT THE SET SCREW CONNECTING THE PLATE AND THE ROD HAD MIGRATED. AFTER IRRIGATION, ROD(S) AND AXIAL DOMINO(S) WERE REPLACED WITH NEW ONE(S).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828724 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention