BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 2801772 · Received October 23, 2012

    Report

    Report Number
    1030489-2012-01932
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 24, 2012
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    K082728
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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 C3-6. IT WAS REPORTED THAT DURING FINAL TIGHTENING OF THE CROSSLINK SETSCREW, THE SET SCREW SHEARED OFF AND WAS LODGED WITHIN THE LOCKING SCREW. THE LOCKING SCREW WAS REMOVED AND THE SET SCREW PIECE WAS RETRIEVED. A DIFFERENT SET SCREW WAS USED AT A DIFFERENT LEVEL WITH NO PROBLEMS. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 LOCKING SCREW, CROSSLINK