BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CALIBRATED TIBIAL CERVICAL SPREADER

    MDR report key: 21276647 · Received January 30, 2025

    Report

    Report Number
    MW5165451
    Event Type
    Injury
    Date Received
    January 30, 2025
    Date of Event
    January 17, 2025
    Report Date
    January 27, 2025
    Manufacturer
    INNOMED, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CERVICAL SPREADER INSTRUMENT BROKE WHILE BEING USED DURING PROCEDURE. ALL PIECES OF THE INSTRUMENT WERE RETRIEVED AND REMOVED FROM STERILE FIELD. NO HARM CAME TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520217 CALIBRATED TIBIAL CERVICAL SPREADER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH INNOMED, INC. 1866 (10)0423GH

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention