BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOLOK RESORBABLE ACL INTERFERENCE SCREW

    MDR report key: 3037244 · Received March 20, 2013

    Report

    Report Number
    9617083-2013-00007
    Event Type
    Other
    Date Received
    March 20, 2013
    Date of Event
    January 1, 2004
    Report Date
    March 15, 2013
    Manufacturer
    BIOCOMPOSITES LTD.
    Product Code
    HWC
    PMA / PMN Number
    K071091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED ROOT CAUSE IS: HISTOLOGICAL STUDIES CONFIRMED A FOREIGN BODY REACTION AGAINST SCREW REMNANTS WITH THE PRESENCE OF MULTINUCLEATED GIANT CELLS.

    Description of Event or Problem · 1

    FOLLOWING A REVIEW OF THE REPORT DETAILS, IT WAS CONCLUDED THAT THE DETAILS OF THIS REPORT MET THE MDR REPORTING CRITERIA. BMJ CASE REPORT: SURGERY PERFORMED WAS RECONSTRUCTION OF THE ANTERIOR CRUCIATE LIGAMENT (ACL) WITH A QUADRUPLE HAMSTRING AUTOGRAFT OF THE LEFT KNEE AFTER A TWISTING SPORTS INJURY, USING A 9X35MM BILOK SCREW. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A FOREIGN BODY REACTION AFTER THE ACL RECONSTRUCTION - THE PATIENT PRESENTED WITH A PREITIBIAL SWELLING AT 30 MONTHS AFTER THE OPERATION. EXPLORATION REVEALED CHALKY, WHITE REMNANTS OF THE SCREW WITH NO EVIDENCE OF INFECTION. HISTOLOGICAL STUDIES CONFIRMED A FOREIGN BODY REACTION AGAINST SCREW REMNANTS WITH THE PRESENCE OF MULTINUCLEATED GIANT CELLS. THE PATIENT HAD A FULL RECOVERY WITH NO COMPROMISE TO GRAFT STABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115307 BIOLOK RESORBABLE ACL INTERFERENCE SCREW BIOLOK SCREW HWC BIOCOMPOSITES LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR