BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DANEK PLATE AND SCREW

    MDR report key: 261927 · Received February 4, 2000

    Report

    Report Number
    1030489-2000-00015
    Event Type
    Injury
    Date Received
    February 4, 2000
    Date of Event
    May 20, 1994
    Report Date
    January 6, 2000
    Manufacturer
    SOFAMOR DANEK MFG.
    Product Code
    HRS
    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: 1987. ON 05/12/1994, PT HEARD CRACKING SOUND IN BACK AND EXPERIENCED PAIN. X-RAYS TAKEN INDICATE A FRACTURE OF HARDWARE. EXPLANTED IN 1994.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention