BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 9294248 · Received November 8, 2019

    Report

    Report Number
    1030489-2019-01291
    Event Type
    Malfunction
    Date Received
    November 8, 2019
    Date of Event
    October 10, 2019
    Report Date
    November 8, 2019
    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. 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 PATIENT WITH PRE-OPERATIVE DIAGNOSIS OF CERVICAL SPONDYLOTIC MYELOPATHY UNDERWENT POSTERIOR CERVICAL SPINAL FIXATION ON 10 OCT 2019. INTRA OP, WHEN PERFORMING FINAL TIGHTENING FOR THE MULTI AXIAL SCREW CROSSLINK LOCKING SCREW PLACED AT TH1, THE HEX PART OF THE MULTI AXIAL SCREW CROSSLINK SET SCREW BROKE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1090141 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0575946W

    Patients

    Seq Age Sex Outcome Treatment
    1