BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 7322132 · Received March 7, 2018

    Report

    Report Number
    1030489-2018-00338
    Event Type
    Malfunction
    Date Received
    March 7, 2018
    Date of Event
    February 5, 2018
    Report Date
    March 7, 2018
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# 7752527, 510K # K082728 AND UDI (B)(4) IS APPROVED FOR SALE IN US. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR FUSION AT C1-C2 DUE TO CERVICAL SPONDYLOTIC MYELOPATHY. INTRA-OP, AFTER INSTALLING MULTI AXIAL SCREW (MAS) CROSSLINK, WHEN MAS CROSSLINK LOCKING SCREW WAS FINALLY TIGHTENED WITH STRAIGHT HEX DRIVER SHAFT, THE TOP OF THE MAS CROSSLINK SET SCREW WAS THREADED. THE SET SCREW WAS NOT REMOVED, AND THE INSTALLATION OF THE CROSSLINK WAS GIVEN UP. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163686 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1