BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER BIOMET STERNALOCK XP RIGID FIXATION SYSTEM

    MDR report key: 23122191 · Received September 22, 2025

    Report

    Report Number
    MW5176345
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    September 16, 2025
    Report Date
    September 17, 2025
    Manufacturer
    ALTO DEVELOPMENT CORP./A&E MEDICAL CORP.
    Product Code
    IKD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WIRE WOULD NOT GO THROUGH THE TIGHTENING MECHANISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541429 ZIMMER BIOMET STERNALOCK XP RIGID FIXATION SYSTEM CABLE, ELECTRODE IKD ALTO DEVELOPMENT CORP./A&E MEDICAL CORP. 479789

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown