BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERNALOCK XP RIGID FIXATION SYSTEM

    MDR report key: 19558874 · Received June 17, 2024

    Report

    Report Number
    MW5156328
    Event Type
    Malfunction
    Date Received
    June 17, 2024
    Date of Event
    June 4, 2024
    Report Date
    June 11, 2024
    Manufacturer
    ZIMMER BIOMET/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

    STERNALOCK XP RIGID FIXATION DEVICE (B)(4) FAILED TO WORK DURING SURGERY (CABG), RETURNED TO VENDOR. WIRES WERE FRAYED WHEN THE BOX WAS OPENED, NOT USED ON THE PATIENT. NO HARM TO THE PATIENT. I APOLOGIZE BUT THE MANUFACTURER IS ZIMMER, NOT (B)(4) ((B)(4) IS THE SUPPLIER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1655674 STERNALOCK XP RIGID FIXATION SYSTEM PLATE, FIXATION, BONE HRS ZIMMER BIOMET/ALTO DEVELOPMENT CORP. 94-1200-08 447365

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male STERNALOCK FIXATION DEVICE