BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MILAGRO INTERFERENCE SCREW

    MDR report key: 2130213 · Received June 16, 2011

    Report

    Report Number
    1221934-2011-00242
    Event Type
    Injury
    Date Received
    June 16, 2011
    Report Date
    June 14, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    HWC
    PMA / PMN Number
    K060830
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOTHING IS BEING RETURNED FOR EVALUATION; THE COMPLAINT DEVICE WAS DISCARDED AT THE USER FACILITY. 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 (B)(4) COMPLAINTS SYSTEM REVEALED ONE OTHER SIMILAR REPORTED ISSUE FOR THIS LOT OF (B)(4) DEVICES THAT WERE RELEASED TO DISTRIBUTION: THE ISSUE WAS UNSUBSTANTIATED. IN ADDITION, A REVIEW INTO THE COMPLAINTS SYSTEM OF ALL OF THE OTHER DEVICE/LOTS THAT ACCOMPANIED THIS COMPLAINT DEVICE/LOT IN THE STERILE LOAD FOR SIMILAR REPORTED ADVERSE EVENTS WAS CONDUCTED; (B)(4). TO DATE: NO FURTHER INFORMATION HAS BEEN RECEIVED; NO DATES OF SURGERIES, NO GRAFT INFORMATION, WHAT LAB TEST WERE PERFORMED AND NO TEST RESULTS, NO FURTHER DETAILS AND NO PATIENT INFORMATION OR STATUS. WE CANNOT DISCERN WHAT THE UNDERLYING CAUSE OR REASON FOR THE REPORTED ADVERSE EVENT MAY BE; HOWEVER, WE WOULD GIVE CONSIDERATION TO OTHER ASPECTS OF THE PROCEDURE; SUCH AS INSTRUMENTATION, STERILITY, THE GRAFT AND ANY OTHER DEVICE TO INCLUDE SUTURE AND NEEDLES AS POSSIBLE SUPPORTERS OF PATIENT REACTION. IT IS VERY POSSIBLE THAT THE ROOT CAUSE FOR THE PATIENT'S ALLEGED REACTION MAY LIE ELSEWHERE AND NOT WITH THE MITEK DEVICE. 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

    OUR AFFILIATE REPORTS TO US THAT THE PATIENT UNDERWENT A SUCCESSFUL KNEE REPAIR (DATE UNKNOWN) WITH THE USE OF A MILAGRO INTERFERENCE SCREW FOR FIXATION. APPROXIMATELY 15 DAYS POST-OP, THE SURGEON SOMEHOW DISCERNED THAT THE PATIENT WAS HAVING AN ALLERGIC REACTION TO THE DEVICE. THE SURGEON CLAIMS THAT LAB TESTING WAS PERFORMED, AND THE RESULTS WERE POSITIVE; NOTHING MORE KNOWN. THE SURGEON FURTHER CLAIMS THAT THE FIXATION DEVICE WAS LOOSE; IT APPEARS THAT HE HAS PERFORMED A RE-SURGERY; REMOVED THE COMPLAINT DEVICE AND THEN DISCARDED IT. THIS IS ALL OF THE INFORMATION MADE AVAILABLE TO MITEK AT THIS TIME. WE HAVE QUESTIONS OUT TO OUR AFFILIATE FOR FURTHER DETAIL AND CLARITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILAGRO INTERFERENCE SCREW SOFT TISSUE FIXATION DEVICE HWC DEPUY MITEK NA 3323865

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention