BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CCD SPINAL FIXATION SYSTEM

    MDR report key: 261853 · Received February 4, 2000

    Report

    Report Number
    1030489-2000-00021
    Event Type
    Injury
    Date Received
    February 4, 2000
    Date of Event
    April 13, 1995
    Report Date
    January 6, 2000
    Manufacturer
    SOFAMOR DANEK EUROPE
    Product Code
    JDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IMPLANT DATE: 1995. COMPUTERIZED AXIAL TOMOGRAPHY SCAN TAKEN 04/12/1995 INDICATE A SCREW IS IMPINGING ON A NERVE. REVISION SURGERY IN 1995 FOR CORRECTION OF SCREW PLACEMENT AND REPLACEMENT OF LOCKING SCREWS. THE REST OF THE DEVICE HAS NOT BEEN REPORTED TO HAVE BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CCD SPINAL FIXATION SYSTEM SPINAL FIXATION SYSTEM JDN SOFAMOR DANEK EUROPE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention