BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY MITEK FULLY ABSORBABLE ANCHORS

    MDR report key: 890524 · Received August 7, 2007

    Report

    Report Number
    1221934-2007-00207
    Event Type
    Injury
    Date Received
    August 7, 2007
    Date of Event
    July 5, 2007
    Report Date
    August 1, 2007
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP CONTACT BY OUR AFFILIATE WAS ABLE TO DETERMINE, THAT A HAMSTRING GRAFT WAS USED IN THE PROCEDURE AND THE PATIENT'S BONE QUALITY WAS NORMAL. THE SURGEON DID NOT PROVIDE ANY OTHER INFORMATION ABOUT THE EVENT, SUCH AS LOT NUMBER, FIXATION, OR IF THE AREA WAS CULTURED. NOTHING IS BEING RETURNED AND NO LOT NUMBER WAS SUPPLIED, BOTH OF WHICH PRECLUDE CONDUCTING A PHYSICAL EVALUATION OR A LOT HISTORY REVIEW. AT THIS TIME NO FURTHER ACTION IS WARRANTED, HOWEVER, IF ANY NEW PERTINENT INFORMATION GERMANE TO THIS ISSUE SURFACES THE INFORMATION WILL BE REFLECTED WITHIN THIS FILE AND A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    FOLLOWING WAS REPORTED TO A DEPUY MITEK MARKETING PERSON FROM OUR AFFILIATE IN ANOTHER COUNTRY. AN ORTHOPAEDIC SURGEON HAS SEEN 2 PATIENTS IN THE LAST 2 WEEKS SHOWING SIMILAR SYMPTOMS. BOTH PATIENTS HAD TIBIAL FIXATION FOLLOWING AN ACL RECONSTRUCTION WITH INTRAFIX. THE PATIENTS RETURNED APPROXIMATELY 2 YEARS POST-OP COMPLAINING OF PAIN OVER THE SITE OF THE SCREW WITH GRANULOSIS AND SYNOVITIS AT THE AREA OF INSERTION. SUBSEQUENTLY THE SCREWS WERE REMOVED. PLEASE ALSO SEE: 1222934-2007-00206

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR