BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 3266402 · Received August 6, 2013

    Report

    Report Number
    1030489-2013-03190
    Event Type
    Injury
    Date Received
    August 6, 2013
    Date of Event
    July 8, 2013
    Report Date
    July 8, 2013
    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

    THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. HOWEVER, THE SUSPECT DEVICES IN USE ARE LOT # H12A1964, LOT # H12B4069, LOT # H12C2248, LOT #H12F2868, AND LOT # H12F2869. (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. MANUFACTURE DATE FOR LOT H12A1964 IS 1/21/2012; MANUFACTURE DATE FOR LOT H12B4069 IS 3/2/2012; MANUFACTURE DATE FOR LOT H12C2248 IS 3/16/2012; MANUFACTURE DATE FOR LOT H12F2868 IS 7/30/2012; MANUFACTURE DATE FOR LOT H12F2869 IS 7/18/2012. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    FILMS WERE SUPPLIED FOR REVIEW: LATERAL VIEW OF CERVICAL CONSTRUCT C1-2, 3, 5, T1. SET SCREWS APPEAR TO HAVE BACKED OUT AT C1. CT VERIFIES PROPER POSITION OF SCREWS WITH DISSOCIATED SET SCREWS AT C1.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR CERVICAL SURGICAL PROCEDURE AT C1-7 TO TREAT OPLL. IT WAS REPORTED THAT THE SETSCREWS AT C1 WERE BACKED OUT. THE PATIENT UNDERWENT A REVISION SURGERY 20 MONTHS POST-OP TO REMOVE AND REPLACE THE SCREWS. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367595 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PLATE, RODS, SCREWS