BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 4352835 · Received December 22, 2014

    Report

    Report Number
    1030489-2014-04815
    Event Type
    Injury
    Date Received
    December 22, 2014
    Date of Event
    November 26, 2014
    Report Date
    November 26, 2014
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL, OPTICAL AND FUNCTIONAL EVALUATION CONFIRM SET SCREW THREADS ARE UNDAMAGED. SET SCREW ROD INTERFACE NODE MORPHOLOGY IS FOUND TO BE FAIRLY TALL AND FLAT, WHICH IS ATYPICAL OF FULL TIGHTENING. FULLY TIGHTENED SET SCREWS NODES ARE TYPICALLY TROUGHED OR CONCAVE AFTER FULL TIGHTENING. NODE DEFORMATION HEIGHT (@ CENTER) SIGNIFICANTLY DIFFERENT THAN TYPICAL FROM BENCH TESTED SAMPLES. ADDITIONALLY, THE ABSENCE OF ROD WITNESS MARKS ON EITHER SIDE OF THE SET SCREW NODE AND ASSOCIATED RODS IS CONSISTENT WITH THE ROD NOT FULLY SEATED IN THE MAS SADDLE AT FINAL TIGHTENING, WHICH MAY HAVE CONTRIBUTED TO SUBSEQUENT ROD MOVEMENT. SET SCREW ROD INTERFACE NODE HEIGHT AND WITNESS MARKS INDICATE RODE MAY NOT HAVE BEEN COMPLETELY SEATED IN MAS AT FINAL TIGHTENING.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). PMA 510(K): 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 ATLANTO-AXIAL FUSION AT C1-2. THREE WEEKS POST-OP IT WAS FOUND THAT THE BONE SCREW WAS LOOSE AT C2 ON THE LEFT SIDE. IT WAS ALSO FOUND THAT THE SET SCREWS WERE LOOSE. THE PATIENT UNDERWENT A REVISION SURGERY TO REPLACE THE C2 PEDICLE SCREW AND FOUR SET SCREWS. THE LEVELS WERE ALSO EXTENDED TO C1-4. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840115 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H5128019

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention