BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS CABLE SYSTEM

    MDR report key: 443656 · Received February 14, 2003

    Report

    Report Number
    1030489-2003-00022
    Event Type
    Injury
    Date Received
    February 14, 2003
    Date of Event
    January 16, 2003
    Report Date
    February 14, 2003
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IMPLANTED IN 2002, FIVE MONTHS-OP, X-RAYS REVEALED A BROKEN CABLE. REVISION SURGERY IN 2002 TO REMOVE THE DEVICE.

    Description of Event or Problem · 1

    IMPLANTED IN 2002. FIVE MONTHS POST-OP, X-RAYS REVEALED A BROKEN CABLE AND SET SCREWS HAD BACKED OUT. REVISION SURGERY 5 MONTHS LATER TO REMOVE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS CABLE SYSTEM CERCLAGE WIRE KWQ WARSAW ORTHOPEDIC INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention