BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK MILAGRO INTERFERENCE SCREW, 9 X 30MM

    MDR report key: 2760424 · Received September 26, 2012

    Report

    Report Number
    1221934-2012-00236
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    September 10, 2012
    Manufacturer
    DEPUY MITEK
    Product Code
    HWC
    PMA / PMN Number
    K060830
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME IN THE INFORMATION GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT

    Additional Manufacturer Narrative · 1

    (B)(6) DAYS HAVE PASSED SINCE THIS ISSUE WAS REPORTED TO MITEK; TO DATE AND NO COMPLAINT DEVICE HAS BEEN RECEIVED, AND NO ADDITIONAL INFORMATION OTHER THAN WHAT WAS ORIGINALLY REPORTED HAS BEEN RECEIVED. A BATCH RECORD REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED NO OTHER SIMILAR COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE CANNOT TELL ANYTHING FROM THIS; WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED ISSUE. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. ALSO, 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.

    Description of Event or Problem · 1

    OUR AFFILIATE IS REPORTING TO US THAT A PATIENT HAD SUCCESSFUL KNEE SURGERY ON (B)(6) 2012. AT SOME TIME SUBSEQUENT TO THE SURGERY, THE PATIENT PRESENTED WITH PAIN AND IT WAS SOMEHOW DETERMINED THAT A RE-SURGERY WAS NEEDED. ON (B)(6) 2012, THE PATIENT UNDERWENT A RE-VISION SURGERY AT WHICH TIME THE SURGEON OBSERVED THAT THE SCREW MILAGRO INTERFERENCE SCREW, 9 X 30MM HAD, TO A DEGREE, BACKED OUT OF THE BONE TUNNEL; HOWEVER THE REPAIR WAS INTACT; THE SURGEON REMOVED THE SCREW. THE SURGEON FURTHER OBSERVED THAT THE PATIENT HAD DEVELOPED "MICRO CRYSTALLINE ARTHRITIS". THIS IS ALL OF THE INFORMATION RECEIVED TO DATE; THERE ARE QUESTIONS OUT TO THE FACILITY FOR FURTHER DETAIL AND CLARITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITEK MILAGRO INTERFERENCE SCREW, 9 X 30MM SOFT TISSUE FIXATION DEVICE HWC DEPUY MITEK NA 3550955

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR