BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WILDE INTRAVERTIBRAL DISC RONGUER, 2.5MM, ST

    MDR report key: 534014 · Received March 17, 2004

    Report

    Report Number
    1121308-2004-00005
    Event Type
    Malfunction
    Date Received
    March 17, 2004
    Report Date
    March 16, 2004
    Manufacturer
    INTEGRA LIFESCIENCES
    Product Code
    HAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SALES REP REPORTED THE INSTRUMENT BROKE WHILE IN USE WITH THE PT. THE BROKEN PIECES WERE RETRIEVED FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WILDE INTRAVERTIBRAL DISC RONGUER, 2.5MM, ST NON-POWERED SURGICAL INSTRUMENT HAE INTEGRA LIFESCIENCES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *