BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTERED HEAD CRCO 48X18

    MDR report key: 22039760 · Received May 16, 2025

    Report

    Report Number
    3014128390-2025-00024
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Date of Event
    May 6, 2025
    Report Date
    May 16, 2025
    Manufacturer
    FX SHOULDER SOLUTIONS DALLAS
    Product Code
    HSD
    UDI-DI
    03701037300428
    PMA / PMN Number
    K123814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WALL OF PLASTIC TRAY WAS DAMAGED, COMPROMISING THE SEAL. CAPA-2024-0039 HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IN A CASE WITH THE SURGEON ON (B)(6) 2025, A 48X18 CENTERED HEAD WAS OPENED DURING SURGERY AND THE TRAY WAS SEEN TO BE CRACKED IN A MANNER THAT BREACHES THE STERILE BARRIER. THE TRAY HAS CRACKED IN THE CORNER OPPOSITE PEELING CORNER, RESULTING IN CHIPPING OF THE SEALING LIP. THE TYVEK BARRIER WAS PEELED BACK APPROXIMATELY 1 INCH AS A RESULT OF THE DAMAGE. THE COMPONENT ITSELF, AND THE PLASTIC WRAPPED SEAL, APPEAR TO NOT HAVE BEEN COMPROMISED. NO SURGICAL DELAY WAS NOTED. CAPA-2024-0039 HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2050229 CENTERED HEAD CRCO 48X18 SHOULDER PROSTHESIS HSD FX SHOULDER SOLUTIONS DALLAS P1660 03701037300428

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown