BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KONIG 9" (22.9 CM) STRAIGHT LAMBOTTE OSTEOTOME WITH 6 MM BLADE

    MDR report key: 10676807 · Received October 14, 2020

    Report

    Report Number
    10676807
    Event Type
    Malfunction
    Date Received
    October 14, 2020
    Date of Event
    October 8, 2020
    Report Date
    October 12, 2020
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    KDG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    OSTEOTOME INSTRUMENT BROKE INTO TWO PIECES, DURING SURGICAL CASE. DURING THE CASE, A 1/4'' OSTEOTOME BROKE INTO TWO PIECES. X-RAY TAKEN, NOT RETAINED. NO HARM TO THE PATIENT. NO CHANGE IN PROCEDURE. PURCHASED THE EQUIPMENT FROM THE COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140392 KONIG 9" (22.9 CM) STRAIGHT LAMBOTTE OSTEOTOME WITH 6 MM BLADE OSTEOTOME KDG MEDLINE INDUSTRIES, INC. MDS3265006

    Patients

    Seq Age Sex Outcome Treatment
    1 23360 DA