BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOLOK RESORBABLE ACL INTERFERENCE SCREW

    MDR report key: 3159173 · Received May 31, 2013

    Report

    Report Number
    9617083-2013-00009
    Event Type
    Other
    Date Received
    May 31, 2013
    Date of Event
    April 25, 2013
    Report Date
    March 15, 2013
    Manufacturer
    BIOCOMPOSITES LTD.
    Product Code
    HWC
    PMA / PMN Number
    K071091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT SHOULD HAVE BEEN SENT BY (B)(6) 2013 - IS 4 DAYS LATE DUE TO ADMINISTRATIVE OVERSIGHT. SUSPECTED ROOT CAUSE IS: FROM REVIEW OF THE INFORMATION PROVIDED, IT IS UNCLEAR INITIALLY WHAT THE EXACT PROBLEM IS IN RELATION TO THE BILOK SCREW, DETAILS OF SURGERY AND WHAT SURGERY IS REQUIRED. MENISCUS SURGERY WOULD NOT REQUIRE USE OF A BILOK SCREW. THREE AND A HALF YEARS POST OPERATIVELY, THE SCREW IS LIKELY TO BE WHOLLY OR PARTIALLY RESORBED. UNABLE TO DETERMINE IF THE SCREW, IMPLANTED IN 2009 IS RESPONSIBLE FOR THE REVISION SURGERY, OR WHETHER THE MORE RECENT SURGERY IN (B)(6) 2012 IS A CONTRIBUTORY FACTOR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE FOLLOWING: OP DATE - (B)(6) 2009 - MEDIAL MENISCUS REFIXATION/ RIGHT KNEE. OP DATE - (B)(6) 2012 - MENISCUS AND MICRO FRACTURING RIGHT KNEE. (B)(6) 2013 - PATIENT HAD SWELLING JUST SUPERIOR TO THE DRILL HOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240376 BIOLOK RESORBABLE ACL INTERFERENCE SCREW BILOK SCREW HWC BIOCOMPOSITES LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention