BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUPLAN

    MDR report key: 9578655 · Received January 10, 2020

    Report

    Report Number
    3009196021-2020-00003
    Event Type
    Malfunction
    Date Received
    January 10, 2020
    Date of Event
    December 10, 2019
    Report Date
    February 7, 2020
    Manufacturer
    MEDCAD
    Product Code
    NDP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS USED FOR TREATMENT AND NOT FOR DIAGNOSIS. IN THE INITIAL REPORT TO MEDCAD ON (B)(6) 2019, THE COMPLAINANT WAS UNABLE TO PROVIDE DETAILED INFORMATION REGARDING THE ALLEGED DEVICE MALFUNCTION. COMPLAINANT WAS CONTACTED ON (B)(6) 2020 FOR ADDITIONAL INFORMATION ABOUT THE ALLEGED DEVICE MALFUNCTION AND THE WEIGHT OF THE PATIENT AT THE TIME OF THE EVENT. MEDCAD DID NOT RECEIVE A RESPONSE TO THIS INQUIRY. COMPLAINANT WAS CONTACTED AGAIN ON (B)(6) 2020 TO FOLLOW UP ON THE INFORMATION REQUESTED; HOWEVER, NO RESPONSE WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND THAT THE DEVICE IN QUESTION WAS PRODUCED IN ACCORDANCE WITH ALL PRODUCTION REQUIREMENTS. NO NONCONFORMANCE WAS IDENTIFIED THROUGHOUT PRODUCTION OF THE DEVICE. INVESTIGATION DID NOT IDENTIFY ANY DEVICE PROBLEM. INVESTIGATION WAS UNABLE TO DETERMINE THE WEIGHT OF THE PATIENT AT THE TIME OF THE EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2019, MEDCAD WAS INFORMED THAT AN ACCUPLAN DENTAL SPLINT DID NOT PROVIDE THE EXPECTED ADVANCEMENT OF THE PATIENT'S MAXILLA. THE DEVICE WAS EXPECTED TO PROVIDE ADVANCEMENT OF APPROXIMATELY 6 TO 9MM, HOWEVER, NO ADVANCEMENT WAS OBSERVED. NO INJURY OR DELAY IN SURGERY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41665 ACCUPLAN FINAL SPLINT NDP MEDCAD 194018 WAL

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR