BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 3564481 · Received January 9, 2014

    Report

    Report Number
    1030489-2014-00084
    Event Type
    Injury
    Date Received
    January 9, 2014
    Report Date
    December 11, 2013
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). LOCATION : HOSPITAL. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 7755278, 510K # K091365 WAS CLEARED IN THE UNITED STATES. THE DEVICE WAS NOT RETURNED FOR EVALUATION, HOWEVER, FILMS WERE SUPPLIED FOR REVIEW WHICH FOUND: COMPLEX CERVICAL CONSTRUCT IS SEEN EXTENDING FROM THE OCCIPUT TO T1. THERE IS POSTERIOR VERTEX INSTRUMENTATION AS WELL AS ACDF C3-C6. THE POSTERIOR INSTRUMENTATION IS SHOWING SEVERAL LOOSE SET SCREWS NEAR THE CROSSLINK AT THE OCCIPITAL CERVICAL JUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL FUSION AT OC-T1. SOMETIME POST-OP, IT WAS FOUND THAT THE PLATE WAS BROKEN WHERE CONNECTED WITH A ROD AND THE SET SCREW OF C2 WAS MIGRATED. THE PATIENT IS ASYMPTOMATIC SO A REVISION SURGERY HAS NOT BEEN SCHEDULED YET. BONE UNION HAS NOT OCCURRED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15388 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0201439W

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR