BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUPLAN

    MDR report key: 8161452 · Received December 13, 2018

    Report

    Report Number
    3009196021-2018-00002
    Event Type
    Injury
    Date Received
    December 13, 2018
    Date of Event
    November 9, 2018
    Report Date
    January 31, 2019
    Manufacturer
    MEDCAD
    Product Code
    NDP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS USED FOR TREATMENT AND NOT FOR DIAGNOSIS. IT WAS REPORTED BY THE SURGEON TO MEDCAD CUSTOMER SERVICE MANAGER ON NOVEMBER 12, 2018, THAT THE INITIAL SURGERY, COMPLETED ON (B)(6) 2018, WENT WELL. IN A CONVERSATION ON NOVEMBER 20, 2018, IT WAS REPORTED BY THE COMPLAINANT THAT THE SURGEON NOTICED A DISCREPANCY BETWEEN THE PATIENT'S DENTAL MIDLINE AND THE PATIENT'S SKELETAL MIDLINE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS LOT NUMBER WAS PERFORMED. ONE NONCONFORMANCE RELATED TO THE PRODUCTION OF THE DEVICE WAS OBSERVED. THE DEVICE WAS REWORKED AND INSPECTED FOR CONFORMANCE TO MEDCAD'S PRODUCTION REQUIREMENTS BEFORE BEING RELEASED FOR DISTRIBUTION. A POST-OPERATIVE CT SCAN PROVIDED BY THE SURGEON WAS REVIEWED BY MEDCAD. REVIEW OF THE CT SCAN DETERMINED THAT THE PATIENT'S ANATOMY WAS POSITIONED APPROXIMATELY 1MM HIGHER THAN EXPECTED, WHICH MAY HAVE CONTRIBUTED TO A SHIFT IN THE PATIENT'S MIDLINE. INVESTIGATION DID NOT DETERMINE A CAUSE FOR THE REPORTED ADVERSE EVENT. A FOLLOW UP EMAIL WAS SENT TO THE COMPLAINANT ON DECEMBER 3, 2018 REQUESTING ADDITIONAL INFORMATION, INCLUDING THE PATIENT'S WEIGHT. A FOLLOW-UP PHONE CALL WAS MADE TO THE COMPLAINANT ON DECEMBER 7, 2018. MEDCAD HAS NOT YET RECEIVED RESPONSES TO THESE REQUESTS.

    Additional Manufacturer Narrative · 1

    EVALUATION FOR THIS EVENT IS STILL IN PROGRESS. A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE ONCE EVALUATION IS COMPLETE OR IF ADDITIONAL INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2018, MEDCAD CUSTOMER SERVICE MANAGER WAS NOTIFIED BY DISTRIBUTOR SALES REPRESENTATIVE THAT THE PATIENT DISPLAYED A DENTAL MIDLINE THAT DID NOT MATCH THE PATIENT'S SKELETAL MIDLINE. THE DISTRIBUTOR SALES REPRESENTATIVE NOTIFIED MEDCAD'S CUSTOMER SERVICE MANAGER THAT THE PATIENT HAD UNDERGONE A SECOND SURGERY ON (B)(6) 2018. ON (B)(6) 2018, THE SURGEON COMMUNICATED TO MEDCAD'S CUSTOMER SERVICE MANAGER THAT THE SURGERY WAS SUCCESSFUL. HOWEVER, ON (B)(6) 2018, AFTER FOLLOWING UP WITH THE PATIENT, THE SURGEON COMMUNICATED THAT THE PATIENT'S MIDLINE WAS NOT IN LINE AND THAT THE PATIENT HAD UNDERGONE A SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999697 ACCUPLAN FINAL SPLINT NDP MEDCAD 183055 AMA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention