BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK, 8-10MM X 30MM INTRAFIX TAPERED SCREW

    MDR report key: 401570 · Received June 26, 2002

    Report

    Report Number
    1221934-2002-00058
    Event Type
    Injury
    Date Received
    June 26, 2002
    Date of Event
    April 9, 2002
    Manufacturer
    MITEK WORLDWIDE
    Product Code
    MBI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT'S ORIGINAL DATE OF ACL RECONSTRUCTION SURGERY WAS 2001. THE 1ST DATE OF SCREW SITE PAIN DOCUMENTED IS IN A PHYSICAL THERAPY NOTE IN 03/2002 AS "PATIENT TENDER OVER PROXIMAL TIBIA" AND AGAIN IN PHYSICIAN NOTE IN 04/2002. SURGEON EVALUATION FOUND THAT THE GRAFT HAD FULLY HEALED HOWEVER THE SCREW WAS BACKING OUT. THE PATIENT HAD SURGERY LATER IN 2002 TO REMOVE MITEK SCREW AND SHEATH REMOVED. AS SURGICAL INTERVENTION WAS REQUIRED AN MDR IS BEING FILED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITEK, 8-10MM X 30MM INTRAFIX TAPERED SCREW FIXATION DEVICE MBI MITEK WORLDWIDE 254603 0108082

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention