BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M3 RIGID FIXATION SYSTEM

    MDR report key: 75160 · Received March 11, 1997

    Report

    Report Number
    2027754-1997-00019
    Event Type
    Injury
    Date Received
    March 11, 1997
    Date of Event
    January 1, 1996
    Report Date
    March 5, 1997
    Manufacturer
    OSTEOMED CORP.
    Product Code
    HWC
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    1.2 MM SCREW HEAD SHEARED. HOWEVER DEVICE WAS RECEIVED WITH NO DOCUMENTATION FOR FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M3 RIGID FIXATION SYSTEM Implant 1.2 MM X 6 MM BONE SCREW HWC OSTEOMED CORP. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention