BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK NON ABSORBABLE ANCHOR IMPLANT

    MDR report key: 2180464 · Received July 27, 2011

    Report

    Report Number
    1221934-2011-00279
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    October 22, 2009
    Report Date
    July 27, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    JDR
    PMA / PMN Number
    K930893
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THE DATE THIS REPORT THE COMPLAINT DEVICE IS NOT BEING RETURNED TO DEPUY MITEK FOR EVALUATION AND ROOT CAUSE ANALYSIS. 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 480 DEVICES WAS PROCESSED WITHOUT INCIDENT. THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. A SEARCH AND REVIEW OF THE DEPUY MITEK COMPLAINT SYSTEM DID NOT REVEAL ANY SIMILAR COMPLAINTS. NO FURTHER OR CORRECTIVE ACTION IS REQUIRED AT THIS TIME. WHEN AND IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REVIEWED FOR RELEVANCE AND FOLLOW-UP REPORT(S) WILL BE FILED AS APPROPRIATE. NO FURTHER OR CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT IS BEING REPORTED ON (B)(6) 2005 A PATIENT HAD SURGERY FOR TWO TEARS IN HIS RIGHT SHOULDER IN WHICH A MITEK SUPER ANCHOR WAS USED. THE PATIENT COMPLAINED OF SORENESS IN HIS RIGHT SHOULDER AND THAT SLEEPING WAS DIFFICULT. TEN (10) MONTHS POST-OP THE PATIENT STILL HAD PAIN. IN 2009 THE PATIENT ISSUES WERE STILL PERSISTING. ON OR ABOUT (B)(6) 2009 THE PATIENT UNDERWENT SURGERY ON HIS RIGHT SHOULDER FOR THE REMOVAL OF WHAT WAS REPORTEDLY A PIECE OF A MITEK SUTURE IN HIS SUBACROMIAL SPACE. IT IS BEING REPORTED THE PATIENT ALSO HAD SYNOVITIS IN THE SUBACROMIAL SPACE AS WELL AS SOME BONE SPURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITEK NON ABSORBABLE ANCHOR IMPLANT ANCHOR IMPLANTS JDR DEPUY MITEK NA 1297980

    Patients

    Seq Age Sex Outcome Treatment
    1