BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTOR3D REVERSE TOTAL SHOULDER ARTHROPLASTY

    MDR report key: 21857658 · Received April 17, 2025

    Report

    Report Number
    3014833750-2025-00006
    Event Type
    Malfunction
    Date Received
    April 17, 2025
    Date of Event
    March 18, 2025
    Report Date
    April 16, 2025
    Manufacturer
    RESTOR3D, INC.
    Product Code
    PHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SIZE OF THE IMPLANT AND THE REQUIRED DRILL GUIDE IS DETERMINED THROUGH A DESIGN CALL WITH SURGEON APPROVAL AND WAS RECORDED CORRECTLY VIA THE RELEVANT INTERNAL DOCUMENTATION. DESPITE APPROPRIATE REVIEW BOTH INTERNALLY AND BY THE OPERATING PHYSICIAN, THE ERROR IN THE SURGICAL PLAN WAS NO IDENTIFIED - MOST LIKELY DUE TO THE DISCREPANCY BEING IN A LARGE, FORMATTED TABLE OF MANY MANUALLY ENTERED WORDS AND DESIGN DETAILS, WHILE THE PAGE OF THE SURGICAL PLAN THAT IS AUTOMATICALLY GENERATED FROM THE DESIGN FILE WAS INDEED CORRECT. EACH SURGICAL PLAN IS MANUALLY GENERATED AND HAS NO EFFECT ON SUBSEQUENT PLANS, THEREFORE THIS IS AN ISOLATED INCIDENT.

    Description of Event or Problem · 0

    DUE TO AN ERROR IN THE SURGICAL GUIDE, THE SURGEON DRILLED FOR A POST 1MM IN DIAMETER LARGER THAN THE TRUE DIAMETER OF THE POST. AS A RESULT, THE SURGEON HAD TO ABORT THE PROCEDURE AND IMPLANT A SPACER INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1764028 RESTOR3D REVERSE TOTAL SHOULDER ARTHROPLASTY REVERSE TOTAL SHOULDER ARTHROPLASTY PHX RESTOR3D, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention