BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 6978971 · Received October 26, 2017

    Report

    Report Number
    1030489-2017-02252
    Event Type
    Malfunction
    Date Received
    October 26, 2017
    Date of Event
    September 28, 2017
    Report Date
    October 26, 2017
    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# 7753500,510K # K082728 AND UDI (B)(4) IS APPROVED FOR SALE IN US. THE DEVICE IS NOT RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT.

    Description of Event or Problem · 1

    PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH INSTABILITY OF C1/2 AND STENOSIS AT C3 AND C6. PATIENT UNDERWENT POSTERIOR FUSION. INTRA-OP, WHEN THE SURGEON WAS PERFORMING FINAL TIGHTENING ON THE LOCKING SCREW AFTER PLACING THE SMALL MULTI-AXIAL SCREW CROSSLINK ON C1 LEVEL, THE HEX HEAD PART OF THE SET SCREW WAS BROKEN. SO THE CROSSLINK COULD NOT BE PLACED.THE SURGEON TRIED TO PLACE MEDIUM MULTI-AXIAL SCREW CROSSLINK ON C2, BUT SAME EVENT HAPPENED AND THE CROSSLINK COULD NOT BE PLACED. THE UPPER PARTS OF THE MAS CROSS LINK SET SCREWS WERE EXPLANTED BUT THE LOWER PARTS ARE STILL IMPLANTED IN THE PEDICLE SCREW HEAD. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758581 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0467684W

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR