BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM GLENOID BASEPLATE

    MDR report key: 24687689 · Received March 25, 2026

    Report

    Report Number
    3014833750-2026-00003
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    February 12, 2026
    Report Date
    March 25, 2026
    Manufacturer
    RESTOR3D, INC.
    Product Code
    PHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE THERE WERE NO PHYSICAL PRODUCTION ISSUES WITH THE DEVICES PROVIDED FOR SURGERY, THE DEVICES PROVIDED DID NOT MATCH THE PATIENT'S ANATOMY AS INTENDED. THERE IS A KNOWN RISK FOR PATIENT SPECIFIC IMPLANTS OF THE PROVIDED DEVICES NOT MATCHING THE ANATOMY, PARTICULARLY FOR REVISION SURGERIES.

    Description of Event or Problem · 0

    PATIENT HAD A CUSTOM SHOULDER GLENOID BASEPLATE DESIGNED DUE TO SEVERE BONE LOSS AND REVISION. INTRAOPERATIVELY, THE FIT OF THE BASEPLATE TO THE PATIENT'S ANATOMY WAS NOT SATISFACTORY AND THE SURGEON DID NOT PROCEED WITH THE OPERATION. THE CT SCAN HAD A LARGE AMOUNT OF METAL ARTIFACT, WHICH CONCEALED THE PRESENCE OF BONE IN THE AREA OF INTEREST AND LED TO A BASEPLATE DESIGN THAT ACCOUNTED FOR MORE EXTENSIVE BONE LOSS THAN WAS ACTUALLY PRESENT. ADDITIONALLY, A GROUP OF FRAGMENTS WHICH WERE INTENDED TO BE REMOVED HAS HEALED BACK INTO THE SCAPULA. THE SURGEON PROVIDED A NEW SCAN WITHOUT HARDWARE PRESENT FOR A REDESIGN AND SUBSEQUENT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403935 CUSTOM GLENOID BASEPLATE CUSTOM SHOULDER BASEPLATE PHX RESTOR3D, INC. 15976-100

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention