BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD SPINAL FIXATION SYSTEM

    MDR report key: 274428 · Received April 19, 2000

    Report

    Report Number
    1030489-2000-00088
    Event Type
    Injury
    Date Received
    April 19, 2000
    Date of Event
    November 17, 1994
    Report Date
    March 23, 2000
    Manufacturer
    MEDTRONIC SOFAMOR DANEK EUROPE
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IMPLANT DATE: 1993. PT FELL ON 02/11/1994. X-RAYS TAKEN 07/29/1994 SHOWS A FRACTURE OF ONE OF THE SCREWS. REVISION SURGERY IN 1994 TO REPLACE DEVICE AT WHICH TIME A PSEUDORATHROSIS WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD SPINAL FIXATION SYSTEM SPINAL FIXAITON SYSTEM KWQ MEDTRONIC SOFAMOR DANEK EUROPE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention