BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERNALOCK X RIGID FIXATION SYSTEM IMPLANT X CABLE PLATE

    MDR report key: 22039229 · Received May 16, 2025

    Report

    Report Number
    MW5170518
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Date of Event
    May 8, 2025
    Report Date
    May 13, 2025
    Manufacturer
    A&E MEDICAL CORP./ALTO DEVELOPMENT CORP.
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ATTEMPTING TO IMPLANT AND X CABLE PLATE WITH THE STERNALOCK XP RIGID FIXATION SYSTEM, SURGEON SAID THE WIRE SEPARATED FROM THE CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166773 STERNALOCK X RIGID FIXATION SYSTEM IMPLANT X CABLE PLATE PLATE, FIXATION, BONE HRS A&E MEDICAL CORP./ALTO DEVELOPMENT CORP. 94-1200-08 472792

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male