BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FULLY ABSORBABLE ANCHORS

    MDR report key: 1230501 · Received July 16, 2008

    Report

    Report Number
    1221934-2007-00186
    Event Type
    Injury
    Date Received
    July 16, 2008
    Report Date
    May 25, 2007
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS STILL IN THE KNEE, AND THERE ARE NO REPORTED PLANS FOR A SECOND SURGERY. THE PRODUCT IS NOT BEING RETURNED, AND NO LOT NUMBERS HAVE BEEN SUPPLIED, BOTH OF WHICH PRECLUDE CONDUCTING EITHER A PHYSICAL EVALUATION, OR A BUILD HISTORY REVIEW TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES, WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. IF HOWEVER, MORE INFORMATION IS RECEIVED THAT IS BOTH PERTINENT, AND GERMANE TO THIS ISSUE, THAT INFORMATION WILL BE EVALUATED, AND THE CONCLUSIONS WILL BE REFLECTED IN A FOLLOW UP REPORT. MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY, AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    A SURGEON REPORTED TO OUR INT'L AFFILIATE THAT A MILAGRO SCREW HAD GONE THROUGH THE TIBIAL TUNNEL, AND IS NOW LODGED IN THE JOINT SPACE. SURGEON HAS DECIDED TO LEAVE THE DEVICE IN THE JOINT SPACE AT THIS TIME. THE SURGEON IS REPORTING THE PATIENT HAS HAD NO ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FULLY ABSORBABLE ANCHORS SOFT TISSUE FIXATION DEVICE MAI DEPUY MITEK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK