BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 8854017 · Received August 2, 2019

    Report

    Report Number
    1030489-2019-00850
    Event Type
    Injury
    Date Received
    August 2, 2019
    Report Date
    August 2, 2019
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    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 # 6959422, 510K # K053483 AND UDI # (B)(4) WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. ALTHOUGH IT IS UNKNOWN WHETHER THIS PRODUCT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. 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 FIXATION AT C5-C6 DUE TO CERVICAL DISLOCATION FRACTURE. ON AN UNKNOWN DATE, POST-OP, THE PATIENT'S CONDITION BECAME WORSE AND THE PATIENT DIED. THE PATIENT HAD CHRONIC DISEASES OF ARRHYTHMIA AND ATRIAL FIBRILLATION. ACCORDING TO THE SURGEON, THERE WAS NO PROBLEM WITH THE INSTRUMENTATION. THE SALES REP HEARD THAT THE PROCEDURE DID NOT CONTRIBUTE TO PATIENT'S DEATH; BUT THE CAUSE OF DEATH WAS SUSPECTED TO BE CEREBRAL INFARCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651524 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other