BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTOR3D

    MDR report key: 17890770 · Received October 6, 2023

    Report

    Report Number
    3014833750-2023-00003
    Event Type
    Injury
    Date Received
    October 6, 2023
    Date of Event
    August 24, 2022
    Report Date
    September 25, 2023
    Manufacturer
    RESTOR3D
    Product Code
    QNN
    PMA / PMN Number
    520(B) EXMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHEN REVIEWING RECORDS FOLLOWING REPORTING OF THE ADVERSE EVENT, RESTORED DISCOVERED THIS DEVICE WAS ASSOCIATED WITH A PREVIOUS INTERNAL COMPLAINT THAT THE TALAR DOME OF THE DEVICE WAS THE INCORRECT SIDE. RESTORED PERFORMED A HEALTH HAZARD ASSESSMENT AT THE TIME WITH THE CLINICIAN, AND DETERMINED THE DEVICE POSED NO ADDITIONAL RISK OF SUBSEQUENT SURGICAL INTERVENTION, AS THE MISMATCH WOULD LIKELY ONLY OCCUR AT THE FAR RANGES OF THE PATIENT'S RANGE OF MOTION.

    Description of Event or Problem · 0

    IN A RETROSPECTIVE STUDY, RESTOR 3D OBTAINED INFORMATION OF ADVERSE EVENTS REGARDING THE STUDY DEVICE. REPORTED EVENT IS THE FOLLOWING: PATIENT EXPERIENCED REVISION ANKLE ARTHROPLASTY WITH SUBTALAR JOINT ARTHRODESIS (STJ) FOR PERSISTENT PAIN AND ARTHRITIS AT THE SUB TALAR JOINT WITH CYSTIC CHANGES PROXIMAL TO TIBIAL IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1711137 RESTOR3D PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT QNN RESTOR3D 9000-0003-B 20201223-DMP-C-01

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male Required Intervention