BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC-SOFAMOR DANEK

    MDR report key: 5084325 · Received September 30, 2004

    Report

    Report Number
    5084325
    Event Type
    Injury
    Date Received
    September 30, 2004
    Report Date
    April 29, 2004
    Manufacturer
    TSRH 3D PRODUCT DIRECTOR - TOM ROEHM
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING LAMINECTOMY WITH FUSION WITH INSTRUMENTATION SCREW EXTENDER ROD TIP BROKE OFF AND WAS RETAINED IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC-SOFAMOR DANEK SCREW EXTENDER ROD KWP TSRH 3D PRODUCT DIRECTOR - TOM ROEHM

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other