BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE SHOULDER SYSTEM

    MDR report key: 24539180 · Received March 6, 2026

    Report

    Report Number
    3006721341-2026-00004
    Event Type
    Malfunction
    Date Received
    March 6, 2026
    Date of Event
    February 6, 2026
    Report Date
    March 4, 2026
    Manufacturer
    LINKBIO CORP.
    Product Code
    QHE
    UDI-DI
    00810022403099
    PMA / PMN Number
    K241470
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    TWO CORE WORKSTATIONS IN INVENTORY WERE FOUND TO HAVE OUT-OF-SYNC TIME/DATE. AN ENGINEER LOGGED INTO THE SERVICE ACCOUNT FOR EACH WORKSTATION TO VIEW THE TIME AND DATE DISPLAYED ON THE TABLET'S CLOCK AND THEY WERE OBSERVED TO BE OUT-OF-SYNC BY SEVERAL MONTHS. AN ENGINEER THEN RE-SYNCED THESE WORKSTATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597925 CORE SHOULDER SYSTEM CORE WORKSTATION QHE LINKBIO CORP. 87-9136 00810022403099

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown