BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEFT INSITU BENDER

    MDR report key: 36791 · Received August 30, 1996

    Report

    Report Number
    1030489-1996-00003
    Event Type
    Malfunction
    Date Received
    August 30, 1996
    Date of Event
    June 25, 1996
    Report Date
    August 8, 1996
    Manufacturer
    SOFAMOR DANEK EUROPE
    Product Code
    HXW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN INSTRUMENT BROKE DURING SURGERY. AS A CONSEQUENCE, THE SURGEON BELIEVES LESS CORRECTION OF THE SPINE OCCURRED RESULTING IN A DELAY OF THE SURGERY OF ABOUT 30 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEFT INSITU BENDER CD HORIZON INSTRUMENT HXW SOFAMOR DANEK EUROPE NA 9549HM

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR