BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 1438736 · Received May 7, 2009

    Report

    Report Number
    1030489-2009-00418
    Event Type
    Malfunction
    Date Received
    May 7, 2009
    Date of Event
    April 8, 2009
    Report Date
    April 8, 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). NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. HOWEVER, THE SUSPECT DEVICES IN USE ARE LOT# W08F4852 AND W08G2185. DEVICE HISTORY RECORDS FOR THESE LOTS 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 # 6950305, 510K # K042498 WAS CLEARED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A CERVICAL PROCEDURE USING POSTERIOR FIXATION AT C1 TO C2. IT WAS REPORTED THAT A PLUG CAME LOOSE AND THE ROD CAME OFF FROM THE PEDICLE SCREW. THE PATIENT REFUSED TO RECEIVE THE REVISION SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ROD: CATALOG # G6900240, LOT #W08G3702| IMPLANTED DATE: