BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 1041213 · Received May 9, 2008

    Report

    Report Number
    1030489-2008-00221
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 8, 2008
    Report Date
    April 8, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    K042524
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVAL. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A CERVICAL PROCEDURE USING POSTERIOR FIXATION AT OCCIPITAL TO T2 FOR SPONDYLOTIC MYELOPATHY. DURING FINAL TIGHTENING, THE CENTERED NUT OF THE CROSS-LINK WAS BROKEN DUE TO EXCESSIVE TIGHTENING. THIS CROSSLINK WAS REPLACED. NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTEX RECONSTRUCTION SYSTEM CROSSLINK KWP WARSAW ORTHOPEDIC INC. NA W05K2195

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR