BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 1547283 · Received November 20, 2009

    Report

    Report Number
    1030489-2009-01101
    Event Type
    Malfunction
    Date Received
    November 20, 2009
    Date of Event
    October 26, 2009
    Report Date
    October 26, 2009
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    NA
    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 SPECS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WHO HAD C1 FRACTURE UNDERWENT A CERVICAL PROCEDURE AT O-C2 USING POSTERIOR FIXATION. WHEN A CROSSLINK WAS BEING INSTALLED AT C1, THE CENTER NUT OF THE CROSSLINK BROKE OFF. THE SURGEON REMOVED THE BROKEN OF CENTER NUT. HE OPTED TO LEAVE THE BROKEN CROSSLINK IN THE PT BECAUSE HE CONCERNED THAT REMOVING THE CROSSLINK WOULD AFFECT THE CONSTRUCT AND PROLONG THE SURGICAL TIME. NO OTHER COMPLICATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTEX RECONSTRUCTION SYSTEM CROSSLINK KWP WARSAW ORTHOPEDIC INC. NA 00036904W

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR