BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTOR3D

    MDR report key: 17890776 · Received October 6, 2023

    Report

    Report Number
    3014833750-2023-00005
    Event Type
    Injury
    Date Received
    October 6, 2023
    Date of Event
    July 26, 2021
    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

    RESTOR3D DESIGNS CUSTOM DEVICES BASED ON THE ORDERING PHYSICIAN'S INPUTS. REVIEW OF DEVICE HISTORY INDICATED RESTOR3D FOLLOWED STANDARD DESIGN AND MANUFACTURING PROCESSES; DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 0

    IN A RETROSPECTIVE STUDY, RESTOR3D 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 PAIN AND INSTABILITY (FOOT ROLLING WHEN WALKING). IMPLANT WAS REMOVED AND CALCANEAL OSTEOTOMY PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239368 RESTOR3D PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT QNN RESTOR3D 9000-0004-B 20200617-DMP-C-01

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female Required Intervention