BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDMOND SPINAL RETRACTOR SHORT TEETH

    MDR report key: 485881 · Received September 23, 2003

    Report

    Report Number
    1121308-2003-00037
    Event Type
    Malfunction
    Date Received
    September 23, 2003
    Report Date
    September 23, 2003
    Manufacturer
    INTEGRA LIFESCIENCES
    Product Code
    GZT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE SCREWDRIVER IS STIRPPING OUT THE HOLE AND LEAVING METAL SHAVINGS IN THE SURGICAL SIGHT AND POSSIBLY IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REDMOND SPINAL RETRACTOR SHORT TEETH NON-POWERED SURGICAL INST. GZT INTEGRA LIFESCIENCES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *