BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC SOFAMOR DANEK

    MDR report key: 404831 · Received July 12, 2002

    Report

    Report Number
    404831
    Event Type
    Malfunction
    Date Received
    July 12, 2002
    Date of Event
    May 20, 2002
    Report Date
    May 21, 2002
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A PT, UNDER SPINAL SURGERY IN 2000 WITH IMPLANTATION OF MEDTRONIC SOFAMOR DANEK PEDICLE SCREW, EXPERIENCED PAIN IN BACK RECENTLY, UNDERWENT SURGERY IN 2002. PEDICLE SCREW NOTED TO BE FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC SOFAMOR DANEK PEDICLE SCREW HWC MEDTRONIC SOFAMOR DANEK * *

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other