BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLE THREAD INTERFERENCE SCREW 9MM X 25MM ROUND HEAD

    MDR report key: 1964338 · Received January 19, 2011

    Report

    Report Number
    1825034-2011-00042
    Event Type
    Injury
    Date Received
    January 19, 2011
    Report Date
    December 22, 2010
    Manufacturer
    BIOMET SPORTS MEDICINE, INC.
    Product Code
    HWC
    PMA / PMN Number
    K982497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER FOUR STATES, "IMPLANTATION OF FOREIGN MATERIALS CAN RESULT IN AN INFLAMMATORY RESPONSE OR ALLERGIC REACTION". (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A PROCEDURE UTILIZING INTERFERENCE SCREWS ON (B)(6) 2009. SUBSEQUENTLY, APPROXIMATELY ONE YEAR LATER, ANTEROMEDIAL SWELLING OF THE TIBIA HAS BEEN DETECTED. MRI REVEALS A PSEUDO-ROUNDNESS OF THE TIBIAL TUNNEL. AS OF THIS DATE, NO REVISION SURGERY HAS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENTLE THREAD INTERFERENCE SCREW 9MM X 25MM ROUND HEAD SCREW, FIXATION HWC BIOMET SPORTS MEDICINE, INC. N/A 725010

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R