BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM REVERSE TOTAL SHOULDER

    MDR report key: 22796770 · Received August 13, 2025

    Report

    Report Number
    3014833750-2025-00013
    Event Type
    Malfunction
    Date Received
    August 13, 2025
    Date of Event
    July 7, 2025
    Report Date
    August 13, 2025
    Manufacturer
    RESTOR3D, INC.
    Product Code
    PHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CASE IS A CUSTOM BASEPLATE FOR A PATIENT WITH A FAILED PRIOR SHOULDER AND THE PHYSICIAN WANTED TO SINGLE-STAGE THE PROCEDURE KNOWING THERE IS A RISK DUE TO METAL ARTIFACTING. THE CASE WENT TO SURGERY AND THE SURGEON DID NOT LIKE THE WAY THE GUIDES WERE FITTING AND THE BONE INTRAOPERATIVELY LOOKED DIFFERENT THAN THE BONE MODEL. INSTEAD OF PROCEEDING, THE SURGEON OPTED TO PUT A CEMENT SPACER IN THE PATIENT AS A BACKUP TO STAGE THE PROCEDURE. THE SURGEON IMMEDIATELY ORDERED A NEW CT AFTER THE CASE AND PROCEEDED WITH A NEW IMPLANT DESIGN FOR A SUBSEQUENT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88012 CUSTOM REVERSE TOTAL SHOULDER CUSTOM SHOULDER BASEPLATE PHX RESTOR3D, INC. 12220 -200, 210, 211, 300, 600 20250527-FML-08-01

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention