BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTOR3D

    MDR report key: 17693598 · Received September 6, 2023

    Report

    Report Number
    3014833750-2023-00002
    Event Type
    Injury
    Date Received
    September 6, 2023
    Date of Event
    June 30, 2021
    Report Date
    September 5, 2023
    Manufacturer
    RESTOR3D
    Product Code
    HWC
    PMA / PMN Number
    520(B) EXMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT-SPECIFIC CUSTOM IMPLANTS ARE PROVIDED ON A PRESCRIPTION BASIS AND THEREFORE MUST MATCH THE SURGEON PROVIDED INPUTS TO TREAT THAT PATIENT'S CONDITION. REVIEW OF PRODUCTION RECORDS DID NOT INDICATE ANY DESIGN OR MANUFACTURING RELATED ISSUES THAT MAY HAVE CONTRIBUTED TO THE EVENT. RESTOR3D CONFIRMED THE IMPLANT LOCATION WAS CORRECT AND FUSION TO THE CUNEIFORMS FUNCTIONED AS INTENDED. DEVICE INTERACTION PROBLEMS WITH THE PATIENT'S ANATOMY COULD BE DUE TO UNEXPECTED CHANGES IN PATIENT ANATOMY DUE TO POTENTIALLY UNDIAGNOSED OR MISDIAGNOSED CHARCOT NEUROPATHY OR MORE WIDESPREAD AVASCULAR NECROSIS.

    Description of Event or Problem · 0

    THE PATIENT-SPECIFIC CUSTOM IMPLANT WAS UNIQUELY DESIGNED ON THE ORDER OF A PHYSICIAN AND IMPLANTED ON (B)(6) 2021. IN AUGUST 2023, RESTOR3D WAS INFORMED BY ANOTHER PHYSICIAN THAT THE PATIENT WILL NEED A REVISION SURGERY DUE TO EROSION AND FRAGMENTATION OF THE TALUS POTENTIALLY SPED UP BY THE ARTICULATING SURFACE OF THE IMPLANT AGAINST THE TALAR HEAD/NECK. THE DEVICE WILL BE EXPLANTED, AND THE PHYSICIAN IS REQUESTING A NEW DEVICE, WITH DIFFERENT REQUESTED FEATURES, FOR THE REVISION SURGERY. A SUPPLEMENTAL REPORT WILL BE FILED IF NEW INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2224494 RESTOR3D PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT HWC RESTOR3D 9000-0042-A 20210618-DMP-C-01

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention