BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DANEK PLATE AND SCREW

    MDR report key: 269686 · Received March 15, 2000

    Report

    Report Number
    1030489-2000-00039
    Event Type
    Injury
    Date Received
    March 15, 2000
    Date of Event
    March 23, 1990
    Report Date
    February 14, 2000
    Manufacturer
    MEDTRONIC SOFAMOR DANEK MFG
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IMPLANT DATE: 1988. PT COMPLAINED OF PAIN. REVISION SURGERY ON 3/23/1990 FOR ANTERIOR INTERBODY FUSION BECAUSE OF PSEUDOARTHROSIS. NOT REPORTED TO HAVE BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DANEK PLATE AND SCREW BONE PLATE AND SCREW HRS MEDTRONIC SOFAMOR DANEK MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention