BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET CABLE SYSTEM

    MDR report key: 3163190 · Received June 11, 2013

    Report

    Report Number
    0002242816-2013-00056
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    EBI, LLC.
    Product Code
    JDQ
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT RETURNED FOR EVALUATION. THE PACKAGE INSERT LISTS AS POSSIBLE ANTICIPATED ADVERSE EFFECTS FOR THE HEALTH CARE PRACTITIONER: "EARLY OR LATE LOOSENING OF THE COMPONENTS." "DISASSEMBLY, FRAYING, KINKING, LOOSENING, BENDING, OR BREAKING OF ANY OR ALL THE COMPONENTS." IT ALSO STATES: "ADDITIONAL SURGERY MAY BE NECESSARY TO CORRECT SOME OF THE ANTICIPATED ADVERSE REACTIONS." "THE ACTUAL TENSION VALUE SHOULD BE DECIDED BY THE SURGEON, TAKING INTO ACCOUNT THE LOCATION AND QUALITY OF THE PATIENTS¿ BONE. HOWEVER, THE TORQUE APPLIED SHOULD NEVER BE GREATER THAN 15IN-LBS. LOADS GREATER THAN THIS VALUE MAY FRACTURE THE BONE AND/OR DAMAGE THE CABLE OR INSTRUMENTS."

    Description of Event or Problem · 1

    IT WAS REPORTED, DURING A SCOLIOSIS PROCEDURE, 2 CABLES WERE BROKEN WHILE BEING TAUTENED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263467 BIOMET CABLE SYSTEM DOUBLE CABLE/CRIMP PKG ASSY TI JDQ EBI, LLC. N/A 893490

    Patients

    Seq Age Sex Outcome Treatment
    1