BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW EXTRACTOR 2.5MM

    MDR report key: 2355534 · Received November 23, 2011

    Report

    Report Number
    2355534
    Event Type
    Malfunction
    Date Received
    November 23, 2011
    Date of Event
    October 12, 2011
    Report Date
    November 22, 2011
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    HWP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    ELDERLY FEMALE UNDERGOING REMOVAL OF PAINFUL EXTENSIVE LUMBAR SEGMENTAL INSTRUMENTATION L3-5: TWO 2.5 MM SET SCREW EXTRACTORS FROM THE SCREW REMOVAL SET BROKE OFF IN THE PATIENT HARDWARE DURING LUMBAR-HARDWARE REMOVAL. ALL PIECES WERE RECOVERED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW EXTRACTOR 2.5MM SET-SCREW EXTRACTORS/SCREW REMOVAL SET HWP DEPUY SPINE, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR