BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 1352451 · Received January 5, 2009

    Report

    Report Number
    1030489-2009-00010
    Event Type
    Malfunction
    Date Received
    January 5, 2009
    Date of Event
    December 7, 2008
    Report Date
    December 7, 2008
    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). DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. 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. IN ADDITION, THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 7002527, 510K # K042524 WAS CLEARED IN THE UNITED STATES.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A CERVICAL PROCEDURE FOR MYELOPATHY AT C2-C7 USING POSTERIOR FIXATION. IT WAS REPORTED THAT THE CENTER NUT OF THE CROSSLINK BROKE OFF DURING TIGHTENING AT C6/7. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTEX RECONSTRUCTION SYSTEM CENTER NUT KWP WARSAW ORTHOPEDIC INC. NA W07J0473

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR