BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 23458737 · Received November 3, 2025

    Report

    Report Number
    3014833750-2025-00016
    Event Type
    Injury
    Date Received
    November 3, 2025
    Date of Event
    February 23, 2023
    Report Date
    October 27, 2025
    Manufacturer
    RESTOR3D, INC
    Product Code
    PHX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BASEPLATE IMPLANT AND ASSEMBLED SCREW BROKE ABOUT 2 YEARS POST-OPERATIVELY. THE SURGEON STATED THE PATIENT WAS PERFORMING "HIGH IMPACT" ACTIVITIES SUCH AS PILATES. THE PATIENT WILL REQUIRE A REVISION SURGERY TO REMOVE THE BROKEN IMPLANT, BUT THE SURGEON REPORTS THE PATIENT IS CURRENTLY SAFE AND STILL HAS ALMOST FULL RANGE OF MOTION. RESTOR3D ANALYSIS SHOWS THE PART WAS DESIGNED AND REVIEWED AS INTENDED. INDEPENDENTLY FROM THIS FAILURE, RESTOR3D PREVIOUSLY INCREASED THE POST CORE DIAMETER IN (B)(6) 2023 FROM 3.86MM TO 4.7MM.

    Description of Event or Problem · 0

    2.5 YEAR POST-OP X-RAY APPEARS WITH BROKEN SCREW AND BROKEN POST. DOCTOR STATED PATIENT HAS BEEN DOING A LOT OF WEIGHT-BEARING EXERCISES WHICH MAY HAVE ATTRIBUTED TO THE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018782 N/A REVERSE TOTAL SHOULDER PHX RESTOR3D, INC LUTTOND_XC1P8-100 20230106-DMP-D-01

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention