BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUPLAN SYSTEM

    MDR report key: 14941154 · Received July 6, 2022

    Report

    Report Number
    3009196021-2022-00006
    Event Type
    Injury
    Date Received
    July 6, 2022
    Date of Event
    June 8, 2022
    Report Date
    July 28, 2022
    Manufacturer
    MEDCAD
    Product Code
    DZJ
    UDI-DI
    00810007630298
    PMA / PMN Number
    K192282
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION INTO THE REPORTED ADVERSE EVENT IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED UPON THE COMPLETION OF THIS INVESTIGATION.

    Additional Manufacturer Narrative · 0

    ON JUNE 8, 2022, IT WAS REPORTED BY DISTRIBUTOR SALES REPRESENTATIVE THAT THE PATIENT'S RIGHT INFERIOR ALVEOLAR NERVE WAS DAMAGED DURING THE BSSO PROCEDURE. THE SURGEON QUESTIONED WHETHER THE NERVE MEASUREMENTS PROVIDED BY MEDCAD IN THE SURGICAL PLAN WERE ACCURATE. THE COMPLAINANT FORWARDED MEDCAD AN IMAGE OF WHERE THE SAGITTAL SPLIT OSTEOTOMY WAS MADE. IT WAS DETERMINED THAT THE SURGEON DEVIATED FROM THE LOCATION OF THE OSTEOTOMY AS SHOWN IN THE APPROVED SURGICAL PLAN BY MAKING THE OSTEOTOMY BEHIND THE SECOND MOLAR, AS OPPOSED TO BETWEEN THE FIRST AND SECOND MOLARS. ON JUNE 9, 2022, MEDCAD MET WITH THE SURGEON TO REVIEW THE SURGICAL PLAN AND THE CT SCAN DATA PROVIDED FOR THE SURGICAL PLANNING. THE SURGEON INDICATED HIS PREFERENCE FOR MAKING SAGITTAL SPLIT OSTEOTOMIES BEHIND THE SECOND MOLAR AS THE REASON FOR DEVIATING FROM THE SURGICAL PLAN COMMUNICATED TO MEDCAD. WHILE REVIEWING THE CT SCAN, THE SURGEON OBSERVED APPROXIMATELY 3 SCAN SLICES IN WHICH A BIFURCATED INFERIOR ALVEOLAR NERVE WAS VISIBLE. THE BIFURCATED PORTION OF THE NERVE WAS NOT DETECTED BY MEDCAD PERSONNEL WHEN THE CT SCAN WAS INITIALLY SEGMENTED BECUASE IT WAS DIFFICULT TO VISUALIZE IN THE SCAN. A POST-OPERATIVE CT SCAN WAS NOT PROVIDED FOR ANALYSIS; HOWEVER, IT IS LIKELY THAT BOTH THE BIFURCATED NERVE THAT WAS NOT IDENTIFIED IN THE SCAN, AS WELL AS THE DEVIATION FROM THE APPROVED SURGICAL PLAN CONTRIBUTED TO THE REPORTED INJURY. THE SURGICAL TEAM WAS REPORTEDLY ABLE TO RESOLVE THE ISSUE DURING SURGERY. THROUGH FOLLOWUP COMMUNICATION WITH THE COMPLAINANT ON JUNE 23, AND AGAIN ON JUNE 30, 2022, MEDCAD REQUESTED ADDITIONAL INFORMATION ABOUT THE PATIENT'S CONDITION. NO RESPONSE TO THESE REQUESTS WAS RECEIVED. IT COULD NOT BE DETERMINED WHETHER THE PATIENT EXPERIENCED ANY ADDITIONAL HEALTH IMPACTS SECONDARY TO THIS EVENT. THE WEIGHT OF THE PATIENT AT THE TIME OF THE EVENT WAS NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S RIGHT INFERIOR ALVEOLAR NERVE WAS DAMAGED DURING THE SAGITTAL SPLIT OSTEOTOMY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S RIGHT INFERIOR ALVEOLAR NERVE WAS DAMAGED DURING THE SAGITTAL SPLIT OSTEOTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048068 ACCUPLAN SYSTEM IMAGE PROCESSING SYSTEM DZJ MEDCAD MC-K000 226881 CRI 00810007630298

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Female Other