BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 8443317 · Received March 22, 2019

    Report

    Report Number
    1030489-2019-00311
    Event Type
    Malfunction
    Date Received
    March 22, 2019
    Date of Event
    February 25, 2019
    Report Date
    March 22, 2019
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    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 PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 6958724; UDI# (B)(4); 510K # K083071 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. 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 CERVICAL FUSION DUE TO CERVICAL SPONDYLOTIC MYELOPATHY. INTRA-OP, DURING SCREW INSERTION, THE IMAGE CAPTURED BY THE O-ARM APPEARED DOUBLY BLURRED ON SCREEN. THE PHYSICIAN RECONFIRMED THAT THE O-ARM STOPPED MOVING AND BREATHING STOPPED. THEN, HE TURNED ON THE O-ARM AGAIN. AS THE IMAGE WAS STILL NOT CLEAR, THE SURGEON INSERTED THE SCREW IN NAVIGATION ON THE BASIS OF AVAILABLE IMAGE. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. POST-OPERATIVELY, SCREW WAS FOUND OUT OF BOUND. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AND NO FURTHER ACTIONS HAVE BEEN PLANNED CURRENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238927 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1