BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 1651244 · Received April 2, 2010

    Report

    Report Number
    1030489-2010-00454
    Event Type
    Injury
    Date Received
    April 2, 2010
    Date of Event
    March 3, 2010
    Report Date
    March 4, 2010
    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

    (B) (4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 7002526, 510K # K042524 WAS CLEARED IN THE UNITED STATES. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVAL. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. 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 PT UNDERWENT A CERVICAL FUSION AT O-C5 USING CROSSLINK POSTERIOR FIXATION. THE CENTER NUT OF THE CROSSLINK WAS BROKEN BY MISTAKE AFTER BEING TIGHTENED. THE PT WAS CLOSED WITH THE BROKEN IMPLANT BEING IMPLANTED. THE SECONDARY SURGERY WAS PERFORMED IMMEDIATELY POST THE INDEX SURGERY TO CORRECT THE EXCESSIVE CERVICAL LORDOSIS. DURING THE SECONDARY SURGERY, THE BROKEN CROSSLINK WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTEX RECONSTRUCTION SYSTEM CROSSLINK KWP WARSAW ORTHOPEDIC INC. NA 0010072W

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention