BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 1645137 · Received March 23, 2010

    Report

    Report Number
    1030489-2010-00356
    Event Type
    Malfunction
    Date Received
    March 23, 2010
    Date of Event
    November 29, 2007
    Report Date
    February 22, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK MANUFACTURING
    Product Code
    KWQ
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LITERATURE ARTICLE CITATION: ARYAN ET AL. STABILIZATION OF THE ATLANTOAXIAL COMPLEX VIA C-1 LATERAL MASS AND C-2 PEDICLE SCREW FIXATION IN A MULTICENTER CLINICAL EXPERIENCE IN 102 PATIENTS: MODIFICATION OF THE HARMS AND GOEL TECHNIQUES. J NEUROSURG SPINE 200; 8:222-229. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A C1-C2 FUSION USING PEDICLE SCREW FIXATION AND RHBMP-2/ACS. AT AN UNKNOWN TIME POST-OP, THE PATIENT PRESENTED WITH ASYMPTOMATIC SCREW BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTEX RECONSTRUCTION SYSTEM BONE SCREW KWQ MEDTRONIC SOFAMOR DANEK MANUFACTURING NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK IMPLANT DATE:| INFUSE BONE GRAFT