BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUPLAN

    MDR report key: 11648702 · Received April 12, 2021

    Report

    Report Number
    3009196021-2021-00003
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Date of Event
    December 8, 2020
    Report Date
    May 21, 2021
    Manufacturer
    MEDCAD
    Product Code
    NDP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021 MEDCAD WAS INFORMED BY COMPLAINANT, THAT THE PATIENT POST-OPERATIVELY PRESENTED A POSTERIOR OPEN BITE. MEDCAD WAS INFORMED THAT THE PATIENT WOULD REQUIRE A REVISION SURGERY TO CORRECT THE SURGICAL OUTCOME. ON (B)(6) 2021 THE COMPLAINANT WAS CONTACTED WITH A FOLLOW-UP, VIA EMAIL BY MEDCAD, REQUESTING MORE INFORMATION REGARDING THE COMPLAINT SUCH AS THE PATIENT'S WEIGHT AT THE TIME OF SURGERY AND DETAILS SURROUNDING THE ISSUE. THIS REQUEST WAS MET WITH NO RESPONSE AND THE COMPLAINANT WAS CONTACTED AGAIN ON (B)(6) 2021, REQUESTING THE ABOVE-MENTIONED INFORMATION. ADDITIONAL FOLLOW-UP REQUESTS WERE MADE ON (B)(6) 2021, VIA EMAIL AND TELEPHONE, BUT WERE YET AGAIN MET WITH NO RESPONSE. ON (B)(6) 2021, THE COMPLAINANT CONTACTED MEDCAD AND SUGGESTED A FOLLOW-UP DIRECTLY WITH THE SURGEON WHO PERFORMED THE SURGERY. A WRITTEN REQUEST WAS SENT DIRECTLY TO THE SURGEON VIA EMAIL ON (B)(6) 2021. THIS WAS ALSO MET WITH NO RESPONSE. NO NON-CONFORMANCES WERE OBSERVED WHEN REVIEWING THE DEVICE HISTORY RECORD FOR THIS CASE. MEDCAD RECEIVED APPROVAL FOR THE PATIENT-SPECIFIC DESIGN ON (B)(6) 2020. THE INSPECTION RECORDS INDICATED THAT THE DEVICE WAS MANUFACTURED ACCORDING TO MEDCAD'S PRODUCTION REQUIREMENTS. THE DEVICE IN QUESTION WAS CONCLUDED TO HAVE AN ACCEPTING DEVICE DISPOSITION. THE CONCLUSION OF THE INVESTIGATION FOUND NO ATTRIBUTABLE ROOT CAUSES FOR THE UNINTENDED RESULTS AND NO DEVICE PROBLEM IDENTIFIED. MEDCAD COULD NOT CONFIRM WHETHER THE PATIENT HAD UNDERWENT ADDITIONAL SURGERY TO CORRECT THE POSTERIOR OPEN BITE.

    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 PATIENT PRESENTED POST-OPERATIVELY WITH A POSTERIOR OPEN BITE. THIS WAS NOT THE NOT THE INTENDED SURGICAL RESULT OF THE PLAN AND THE PATIENT WILL REQUIRE A REVISION SURGERY TO CORRECT THE SURGICAL OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546755 ACCUPLAN FINAL SPLINT NDP MEDCAD 205233 TAN

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization