BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM REVERSE TOTAL SHOULDER

    MDR report key: 24911654 · Received April 17, 2026

    Report

    Report Number
    3014833750-2026-00004
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Date of Event
    March 26, 2026
    Report Date
    April 17, 2026
    Manufacturer
    RESTOR3D, INC.
    Product Code
    PHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SURGICAL PROCEDURE WAS COMPLETED AS INTENDED WITH ONLY A 30-45 MIN DELAY. THE PATIENT WAS CLOSED FOLLOWING PLACEMENT OF THE BASEPLATE BUT SURGERY WAS FINISHED WITHOUT SCREWS THE SURGEON INTENDED TO PLACE DUE TO SCREW SEATING ISSUE.

    Description of Event or Problem · 0

    CASE WAS PLANNED TO USE 5.0-MM AND 3.5-MM DIAMETER LOCKING SCREWS. THE 5.0-MM SCREWS DID NOT FIT INTRAOPERATIVELY AND THE SURGEON WAS ONLY ABLE TO IMPLANT ONE OUT OF FIVE OF THE 5.0-MM LOCKING SCREWS. THE SURGEON WAS ABLE TO IMPLANT ALL THREE 3.5-MM LOCKING SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41592 CUSTOM REVERSE TOTAL SHOULDER CUSTOM REVERSE TOTAL SHOULDER PHX RESTOR3D, INC. 15903-100

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female