BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 8411438 · Received March 12, 2019

    Report

    Report Number
    1030489-2019-00263
    Event Type
    Injury
    Date Received
    March 12, 2019
    Report Date
    March 12, 2019
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    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# 6958720, 510K# K143471 AND UDI (B)(4) IS APPROVED FOR SALE IN US. 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. 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 SINGLE LEVEL CERVICAL FUSION SURGERY DUE TO DISLOCATION FRACTURE OF C4-5. POST-OP, THE IMPLANTED SCREW DEVIATED TOWARD OUTSIDE AND ANGLE OF SCREW WAS SLIGHTLY UPRIGHT. ALTHOUGH IT HAS NOT BEEN NOTICED INTRA-OPERATIVELY THAT THE SCREW DEVIATED OR NOT BUT IT WAS FOUND AFTER THE OPERATION IN CT SCAN THAT THE SCREW DEVIATED. PATIENT HAD CEREBRAL INFARCTION AND VERTEBRAL ARTERY (VA) ALSO GOT INJURED. EMBOLIZATION WAS PERFORMED FOR THE TREATMENT OF VA INJURY AND ALSO TREATMENT FOR CEREBRAL INFRACTION HAS BEEN COMPLETED UNDER THE NEUROSURGERY PHYSICIAN. NO REVISION SURGERY HAS BEEN PLANNED FOR THE REMOVAL OF DEVIATED SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204455 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other