BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 1509546 · Received October 15, 2009

    Report

    Report Number
    1030489-2009-00941
    Event Type
    Injury
    Date Received
    October 15, 2009
    Date of Event
    September 18, 2009
    Report Date
    September 16, 2009
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG #6955240, 510K # K003780 WAS CLEARED IN THE UNITED STATES. DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. AP/LATERAL VIEW OF VERTEX/LEGACY HYBRID FROM OCCIPUT TO T7 FILMS IN 2009 SHOW ALL RODS INTACT. FILM IN 2008, VERIFIED VERTEX ROD FRACTURE JUST BELOW OCCIPITAL FIXATION POINTS. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A CERVICAL PROCEDURE TO FUSE O/T7 USING POSTERIOR FIXATION. IT WAS RECENTLY REPORTED THAT A ROD BROKE AT O-C2. FUSION WAS NOT COMPLETED. THE PATIENT COMPLAINED OF PAIN. A REVISION SURGERY WAS PERFORMED APPROXIMATELY THREE AND A HALF MONTHS POST OP TO REMOVE THE BROKEN ROD. THE PATIENT PAIN REPORTEDLY RESOLVED AFTER THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTEX RECONSTRUCTION SYSTEM ROD KWP WARSAW ORTHOPEDIC INC. NA W08A4217

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention