BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTOR3D

    MDR report key: 17890775 · Received October 6, 2023

    Report

    Report Number
    3014833750-2023-00004
    Event Type
    Injury
    Date Received
    October 6, 2023
    Date of Event
    August 25, 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
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF DEVICE DESIGN AND PRODUCTION RECORDS REVEALED NO ERRORS IN DESIGN NOR PRODUCTION THAT WOULD HAVE CAUSED THE ADVERSE EVENT.

    Description of Event or Problem · 0

    IN A RETROSPECTIVE STUDY, RESTORED OBTAINED INFORMATION OF ADVERSE EVENTS REGARDING THE STUDY DEVICE. THE EVENT WAS NOT REPORTED AS A COMPLAINT BY THE CUSTOMER, AND THERE WAS NO DEVICE DEFECT OR MALFUNCTION RELATED TO THE DEVICE AT THE TIME OF SURGERY. REPORTED EVENT IS THE FOLLOWING: PATIENT EXPERIENCED PROSTHETIC LOOSENING AND PAIN LEADING TO POSTOP ARTHRITIS AND TIBIAL CYSTIC FORMATION; HAD A REVISION TOTAL ANKLE REPLACEMENT (TAR), TENDON REPAIR, AND REMOVAL OF THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239367 RESTOR3D PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT QNN RESTOR3D 9000-0003-A 20210127-DMP-C-01

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention