BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUPLAN

    MDR report key: 10368594 · Received August 5, 2020

    Report

    Report Number
    3009196021-2020-00006
    Event Type
    Malfunction
    Date Received
    August 5, 2020
    Date of Event
    July 8, 2020
    Report Date
    September 17, 2020
    Manufacturer
    MEDCAD
    Product Code
    NDP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF THE COMPLAINT REPORT, MEDCAD CONTACTED THE SURGEON VIA EMAIL ON JULY 08, 2020 TO OBTAIN ADDITIONAL INFORMATION ABOUT THE REPORTED MALFUNCTION. THE SURGEON INDICATED THAT TO CORRECT THE DISCREPANCY IN THE PATIENT'S LOWER JAW POSITION, SURGERY WAS PERFORMED ON THE PATIENT'S UPPER JAW AS PLANNED, THEN, "WITH THE MAXILLA AND FINAL SPLINT USED WE REMOVED ALL HARDWARE FROM THE MANDIBLE AND RE-PLATED IT IN ITS CORRECT POSITION." THE SURGEON STATED, "AGAIN, THE PATIENT WILL HAVE AN EXCELLENT RESULT AND SHE IS DOING FINE THIS MORNING AT HER POSTOPERATIVE CHECK." THE SURGEON REQUESTED TO MEET WITH MEDCAD TO FURTHER DISCUSS POTENTIAL CAUSES FOR THE OBSERVED DISCREPANCY. ON AUGUST 07, 2020, MEDCAD CONTACTED THE SURGEON'S OFFICE VIA TELEPHONE TO ARRANGE A MEETING WITH THE SURGEON. ON AUGUST 12, 2020, MEDCAD FOLLOWED UP WITH THE SURGEON'S OFFICE VIA EMAIL TO REQUEST THE MEETING. MEDCAD'S REPEATED REQUESTS TO MEET WITH THE SURGEON TO FURTHER DISCUSS THE CASE WERE NOT MET. COMMUNICATION WITH THE SURGEON COULD NOT DETERMINE THE CAUSE OF THE REPORTED MALFUNCTION OR THE WEIGHT OF THE PATIENT AT THE TIME OF THE EVENT. THE DEVICE HISTORY RECORD WAS REVIEWED. PRODUCTION RECORDS DID NOT INDICATE ANY NONCONFORMANCE. IN-PROCESS INSPECTION RECORDS INDICATED THAT THE DEVICE IN QUESTION WAS PRODUCED IN ACCORDANCE WITH ALL PRODUCTION REQUIREMENTS. INVESTIGATION INTO THE REPORTED EVENT WAS UNABLE TO IDENTIFY A DEVICE PROBLEM. THE CAUSE OF THE REPORTED MALFUNCTION COULD NOT BE DETERMINED. A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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

    IT WAS REPORTED THAT THE USE OF THE INTERMEDIATE SPLINT DID NOT RESULT IN THE EXPECTED ADVANCEMENT OF THE MANDIBLE. THE SURGEON WAS EXPECTING 9 MM OF ADVANCEMENT; HOWEVER, WHEN THE SPLINT WAS REMOVED, "THE MANDIBLE IMMEDIATELY FELL BACK APPROXIMATELY 1/2 CM." THIS DISCREPANCY WAS CORRECTED DURING SURGERY AND THERE WAS NO IMPACT TO THE PATIENT AS A RESULT OF THE REPORTED MALFUNCTION. ACCORDING TO THE SURGEON, THIS WAS A "MINOR DISCREPANCY" AND THAT THE PATIENT "WILL HAVE AN EXCELLENT RESULT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834188 ACCUPLAN INTERMEDIATE SPLINT NDP MEDCAD 204813 BOA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR