BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UCSS SCREW SET

    MDR report key: 1471444 · Received June 4, 2009

    Report

    Report Number
    1030489-2009-00517
    Event Type
    Malfunction
    Date Received
    June 4, 2009
    Report Date
    May 11, 2009
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    MRW
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). PRODUCT REMAINS IMPLANTED, PRODUCT RETURN IS NOT POSSIBLE. THE FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION EITHER. 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 # 873-032, 510K # K003928 WAS CLEARED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A BROOKS METHOD USING THE CABLE AND CERVICAL POSTERIOR FIXATION. IT WAS REPORTED THAT THE SCREW BACKED OUT A MONTH POST OP. NO PROCEDURE WAS PERFORMED TO REPLACE THE IMPLANT. FUSION REPORTEDLY WAS COMPLETED AT THE END OF (B) (6) 2009. NO OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UCSS SCREW SET BONE SCREW MRW WARSAW ORTHOPEDIC INC. NA W05K3835

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR