BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9-10MM STANDARD EZLOC FEM FIXA

    MDR report key: 3901629 · Received June 30, 2014

    Report

    Report Number
    0001825034-2014-05736
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 9, 2014
    Report Date
    September 10, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBI
    PMA / PMN Number
    PK041261
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 WARNINGS IT STATES: INADEQUATE FIXATION AT THE TIME OF SURGERY CAN INCREASE THE RISK OF LOOSENING AND MIGRATION OF THE DEVICE OR TISSUE SUPPORTED BY THE DEVICE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECT INITIAL PROCEDURE DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN ACL RECONSTRUCTION PROCEDURE UTILIZING A FEMORAL FIXATION DEVICE ON (B)(6) 2008. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 DUE TO GRAFT LAXITY WITH THE ACL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN ACL RECONSTRUCTION PROCEDURE UTILIZING A FEMORAL FIXATION DEVICE ON (B)(6) 2009. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 DUE TO GRAFT LAXITY WITH THE ACL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379907 9-10MM STANDARD EZLOC FEM FIXA FASTENER, FIXATION MBI BIOMET ORTHOPEDICS N/A 952980

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R