BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM RTSA

    MDR report key: 24654119 · Received March 20, 2026

    Report

    Report Number
    3014833750-2026-00002
    Event Type
    Malfunction
    Date Received
    March 20, 2026
    Date of Event
    February 19, 2026
    Report Date
    March 20, 2026
    Manufacturer
    RESTOR3D, INC.
    Product Code
    PHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF PRODUCTION RECORDS REVEALS NO NONCONFORMANCES RELATED TO THE PHYSICAL PRODUCTION OF THE DEVICE IN QUESTION. THIS EVENT IS LIMITED TO THE DIGITAL INPUTS OF THIS PARTICULAR CASE, AS SCANS FOR TWO DIFFERENT PATIENTS WERE UPLOADED BY AN EXTERNAL USER TO THE IMAGING SLOT FOR THE CASE. DIGIAL PROCESS CONTROL STEPS TO VERIFY PATIENT IDENTITY AND DOB FAILED TO CATCH THE DISCREPANCY, SO THE PATIENT-SPECIFIC COMPONENTS WERE DESIGNED TO THE INCORRECT SCAN. DESPITE THE PROCESS FAILURE, THE SURGEON WAS ABLE TO ACHIEVE A POSITIVE, ACCEPTABLE RESULT INTRAOPERATIVELY AND THE PATIENT IS DOING WELL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT, INSTRUMENTS, AND MODEL PROVIDED FOR A PATIENT-SPECIFIC CASE DID NOT MATCH THE PATIENT'S ANATOMY. THE SURGEON REPORTED THAT DESPITE THE DIFFERENCE IN SIZE, THE OPERATION WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711327 CUSTOM RTSA REVERSE TOTAL SHOULDER ARTHROPLASTY PHX RESTOR3D, INC. 16190-100, -200, -300, -400 16190

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown