BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK MILAGRO INTERFERENCE SCREW, 8 X 23MM

    MDR report key: 3114323 · Received May 15, 2013

    Report

    Report Number
    1221934-2013-00135
    Event Type
    Injury
    Date Received
    May 15, 2013
    Report Date
    May 14, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    HWC
    PMA / PMN Number
    E370858
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    67 DAYS HAVE PASSED SINCE THIS ISSUE WAS REPORTED TO MITEK, AND TO DATE, DESPITE OUTREACHES FOR FURTHER DETAIL, NO ADDITIONAL INFORMATION OTHER THAN WHAT WAS ORIGINALLY REPORTED HAS BEEN RECEIVED. OUR AFFILIATE HAS MADE NUMEROUS ATTEMPTS TO GATHER FURTHER INFORMATION, DATA AND CLARITY FROM THE USER FACILITY AND THE SURGEON WITHOUT SUCCESS. THE SURGEON SHUT DOWN AND WILL NOT ELABORATE ANY FURTHER THAN HE HAS. 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.

    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

    Description of Event or Problem · 1

    PATIENT ISSUE - INFECTION/REACTION AND RE-SURGERY: OUR AFFILIATE IS REPORTING TO US THAT THE SURGEON HAS INFORMED THEM THAT HE HAS HAD 6 HISTORICAL KNEE REPAIR PROCEDURES IN WHICH VARIOUS MILAGRO SCREWS WHERE USED FOR FIXATION. IN SOME OF THESE CASES, THE PATIENTS DEVELOPED CYST FORMATIONS, AND SOME WITH NO INTEGRATION OF SCREW AND TENDON. THE SURGEON TALKS ABOUT REVISIONS AFTER 6 MONTHS; THE SCREWS APPEARED WITH THE CONSISTENCY OF TOOTH PASTE; THERE WAS FLUID OOZING OUT OF THE JOINT SPACE THROUGH THE SCREW WITH SIGNIFICANT INFLAMMATORY TISSUE RESPONSE. NO OTHER DETAILS HAVE BEEN GIVEN: NO PROCEDURE DATES, NOT LOT NUMBERS, NO PATIENT PERTINENT HISTORY, NO PRESENTATION DETAILS, NO TREATMENT DETAILS, NO TEST DATA, ETC. NOTHING BEING RETURNED, COMPLAINT DEVICE DISCARDED AT USER FACILITY. ALSO SEE ASSOCIATED MDRS 1221934-2013-00133, 1221934-2013-00134, 1221934-2013-00136, 1221934-2013-00137 AND 1221934-2013-00138.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215685 MITEK MILAGRO INTERFERENCE SCREW, 8 X 23MM SOFT TISSUE FIXATION DEVICE HWC DEPUY MITEK NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1