BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 8694391 · Received June 13, 2019

    Report

    Report Number
    1030489-2019-00620
    Event Type
    Injury
    Date Received
    June 13, 2019
    Report Date
    July 9, 2019
    Manufacturer
    WARSAW ORTHOPEDICS
    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 PART IS NOT APPROVED FOR SALE IN THE UNITED STATES BUT A SIMILAR PART WITH CATALOGUE # 7755275, 510K # K080805 AND UDI # (B)(4) APPROVED FOR SALE IN THE US. 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.

    Additional Manufacturer Narrative · 1

    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 OCCIPITO POSTERIOR CERVICAL FUSION FROM O-C7. IN WHICH, THE RODS HAVE BEEN IMPLANTED. POST-OP, THE ROD NEAR C1 LEVEL WAS BROKEN. AS TO HEALTH DAMAGE IN THE PATIENT, THE INSTABILITY DUE TO ROD BREAKAGE REMAINED IN THE PATIENT. HENCE, PATIENT UNDERWENT A REVISION SURGERY FOR THE REPLACEMENT OF THE BROKEN ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491956 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0537581W

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R