BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUPLAN

    MDR report key: 11849419 · Received May 19, 2021

    Report

    Report Number
    3009196021-2021-00004
    Event Type
    Malfunction
    Date Received
    May 19, 2021
    Date of Event
    April 20, 2021
    Report Date
    May 18, 2021
    Manufacturer
    MEDCAD
    Product Code
    NDP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ON APRIL 20, 2021 MEDCAD WAS INFORMED BY COMPLAINANT VIA TEXT MESSAGES AND PHONE CALL REGARDING AN ALLEGED MALFUNCTION RELATING TO THE INTERMEDIATE SPLINTS USED IN CASE (B)(4) HOD. THE SPLINT IN QUESTION WAS PLACED INTO OCCLUSION DURING SURGERY AND WAS OBSERVED TO PROMOTE MINIMAL ADVANCEMENTS ON THE RIGHT LEFORT SEGMENT AND THE LEFT SEGMENT SHOWED A 6MM ADVANCEMENT. THESE UNINTENDED ADVANCEMENTS SEEMED TO "MIRROR" WHAT WAS PRESENTED IN THE SURGICAL PLAN. THE FINAL SPLINTS THAT WERE SUPPLIED WERE NOT USED IN THE SURGERY. THE DOCTOR WHO PERFORMED THE SURGERY FOR THIS CASE, INDICATED THAT "THE PATIENT LOOKS GOOD" AFTER A ONE-WEEK PATIENT FOLLOW-UP, IN AN IN-PERSON CONVERSATION WITH THE CUSTOMER SERVICES MANAGER ON (B)(6) 2021. ATTEMPTS TO COLLECT INFORMATION, SUCH AS THE PATIENT'S WEIGHT AT THE TIME OF SURGERY AND WHETHER THE SURGERY WAS PROLONGED, WERE MADE DURING THIS CONVERSATION BUT WAS NOT PROVIDED. SURGEON APPROVAL FOR THE SPLINT DESIGN WAS CONFIRMED ON (B)(6) 2021. DEVICE HISTORY RECORD REVIEW OF CASE (B)(4) HOD IDENTIFIED NO NON-CONFORMANCES RELATED TO THE PRODUCTION OF THE DEVICE IN QUESTION AND WAS MANUFACTURED ACCORDING TO MEDCAD'S PRODUCTION REQUIREMENTS. INSPECTION OF THE DEVICE WAS PERFORMED ON (B)(6) 2021 AND PASSED FIT INSPECTION AGAINST PATIENT-SPECIFIC DENTAL MODELS. CONCLUSION OF THIS INVESTIGATION FOUND NO CLEAR ROOT-CAUSE FOR THIS ALLEGED MALFUNCTION.

    Description of Event or Problem · 1

    THE MAXILLARY AND MANDIBULAR ADVANCEMENTS THAT WERE CALLED OUT IN THE ORTHOGNATHIC DIGITAL SURGICAL PLAN (DSP), WERE NOT REFLECTIVE OF WHAT WAS OBSERVED DURING THE SURGERY WHEN THE INTERMEDIATE SPLINTS WERE USED. THE ORTHOGNATHIC DSP CALLED FOR 6.1MM ADVANCEMENT ON THE PT. RIGHT LEFORT SEGMENT AND 0.8MM ADVANCEMENT ON THE PT. LEFT LEFTORT SEGMENT, BUT WHEN THE INTERMEDIATE SPLINTS WERE PLACED INTO OCCLUSION DURING SURGERY, THE MAXILLARY ADVANCEMENTS WERE OBSERVED TO BE THE OPPOSITE OF THE PLAN'S INTENDED ADVANCEMENTS. SIMILARLY, THE MANDIBULAR ADVANCEMENTS WERE OBSERVED TO BE THE OPPOSITE AS WHAT WAS CALLED OUT IN THE ORTHOGNATHIC DSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745602 ACCUPLAN INTERMEDIATE SPLINT NDP MEDCAD 215631 HOD

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR