BEUDAMED
    FDA Adverse Event Other Summary report: N

    OSTEOMED LAG SCREW

    MDR report key: 75204 · Received March 11, 1997

    Report

    Report Number
    75204
    Event Type
    Other
    Date Received
    March 11, 1997
    Date of Event
    December 6, 1996
    Report Date
    January 16, 1997
    Manufacturer
    OSTEOMED CORP.
    Product Code
    HWC
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CO 2.4 MM DIAMETER/ 18MM LENGTH CORTICAL (LAG) SCREW IMPLANTED DURING BUTIONECTOMY AND TRANSVERSE OSTEOLTOMY AND TRANSVERSAL WITH INTERNAL FIXATION ON 8/23/96. SCREW BROKE INTO 2 PIECES AND CAUSED PAIN. BONE UNION AND ALIGNMENT NOT AFFECTED. SCREW PIECES SURGICALLY REMOVED ON 12/6/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEOMED LAG SCREW Implant 2.4 MM DIAMETER/18MM LENGTH HWC OSTEOMED CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other