BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOMET SIZER

    MDR report key: 61788 · Received January 8, 1997

    Report

    Report Number
    61788
    Event Type
    Other
    Date Received
    January 8, 1997
    Date of Event
    December 2, 1996
    Report Date
    December 4, 1996
    Manufacturer
    BIOMET CO.
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY SIZER BROKE OFF, WEDGING BETWEEN FEMUR & ACL GRAFT. COMPANY RECOMMENDED LEAVING SIZER PIECE IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET SIZER 7MM SIZER FOR BIOMET ACL SCREWS LXH BIOMET CO. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other