BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTEOMED

    MDR report key: 88091 · Received April 30, 1997

    Report

    Report Number
    2027754-1997-00022
    Event Type
    Injury
    Date Received
    April 30, 1997
    Date of Event
    February 22, 1997
    Report Date
    April 28, 1997
    Manufacturer
    OSTEOMED CORP.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE HEAD OF THE SCREW BROKE OFF WHILE BEING INSERTED IN THE PT ON 2/22/97. A PORTION OF THE SCREW REMAINS IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEOMED Implant MINI BONE SCREW HWC OSTEOMED CORP. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention