BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM TATTR + STJ FUSION

    MDR report key: 22861927 · Received August 21, 2025

    Report

    Report Number
    3014833750-2025-00014
    Event Type
    Malfunction
    Date Received
    August 21, 2025
    Report Date
    August 21, 2025
    Manufacturer
    RESTOR3D, INC.
    Product Code
    QNN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INCORRECT IMAGE SERIES WAS SELECTED DURING SCAN ASSIGNMENT AND SEGMENTATION OF THE PATIENT'S ANATOMY. THE SCAN THAT WAS ULTIMATELY SELECTED FOR SEGMENTATION WAS THE OLDER OF THE TWO SERIES PROVIDED BY THE SURGEON; THE SELECTED SCAN PREDATING CHANGES TO THE PATIENT'S ANATOMY THAT TOOK PLACE BETWEEN SCANS-- A KEY FEATURE IN DETERMINING DESIGN INPUTS FOR THE REQUESTED DEVICE. THE DISCREPANCY WAS NOT IDENTIFIED THROUGH MULTIPLE PROCESS CHECKS, INCLUDING THE ULTIMATE REVIEW AND APPROVAL THAT WAS PERFORMED BY THE SURGEON, THOUGH IT WAS CAUGHT ON THE SCHEDULED DAY OF SURGERY, PROMPTING A SAME-DAY CANCELLATION AND DELAYING TREATMENT FOR THE PATIENT. UPON REVIEW OF PRODUCTION RECORDS, NO OTHER CASES HAVE LEFT THE MANUFACTURING FACILITY WITH THE INCORRECT IMAGE SERIES SELECTED FOR DEVICE DESIGN. APPROPRIATE UPDATES TO RELEVANT WORK INSTRUCTIONS HAVE BEEN MADE TO MORE EFFECTIVELY IDENTIFY THESE ERRORS IN THE FUTURE.

    Description of Event or Problem · 0

    OPERATION WAS CANCELED SAME-DAY AFTER DEVICE WAS PROVIDED HAVING BEEN DESIGNED TO OUT-OF-DATE SCAN, CAUSING DELAY OF CARE FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2204681 CUSTOM TATTR + STJ FUSION TOTAL ANKLE/TOTAL TALUS REPLACEMENT + SUBTALAR JOINT FUSION QNN RESTOR3D, INC. 13413-100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown