BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSHAPE

    MDR report key: 13366756 · Received January 27, 2022

    Report

    Report Number
    3009196021-2022-00003
    Event Type
    Malfunction
    Date Received
    January 27, 2022
    Date of Event
    December 30, 2021
    Report Date
    January 27, 2022
    Manufacturer
    MEDCAD
    Product Code
    GXN
    UDI-DI
    00810007630120
    PMA / PMN Number
    K100684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE COMPLAINANT STATED THAT THE SURGEON OBSERVED INTERFERENCE BETWEEN THE EDGE DEVICE AND THE PATIENT'S CRANIAL BONE. THE SURGEON REPORTEDLY MODIFIED THE EDGE FIT ACCORDING TO THE INSTRUCTIONS FOR USE PROVIDED. AFTER MODIFYING THE FIT THE SURGEON USED CRANIAL MESH TO COVER THE RESULTING GAP AND COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF HARM TO THE PATIENT AS A RESULT OF THIS EVENT. A REVIEW OF DEVICE HISTORY RECORD FOUND THAT THE DEVICE WAS MANUFACTURED AS DESIGNED AND AS REQUESTED BY THE SURGEON. UPON EXAMINATION OF THE PATIENT'S CT SCAN PROVIDED TO MEDCAD, THERE WAS EVIDENCE OF IMAGE ARTIFACTS SUGGESTING PATIENT MOVEMENT DURING THE SCAN. MEDCAD'S PUBLISHED CT SCAN INSTRUCTIONS SPECIFY THAT MOTION ARTIFACTS MUST BE AVOIDED AS THEY CAN NEGATIVELY IMPACT THE FUNCTIONING OF FINAL DEVICE. THE DEVICE HISTORY RECORD INDICATED THAT THE CT SCAN PROVIDED AS INPUT TO MEDCAD WAS REVIEWED AND APPROVED; HOWEVER, THE PATIENT MOVEMENT WAS NOT INITIALLY DETECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT-SPECIFIC CRANIAL IMPLANT DID NOT ADEQUATELY FIT THE PATIENT'S CRANIAL DEFECT. ADDITIONAL CRANIAL MESH WAS REQUIRED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85501 ACCUSHAPE PEEK PATIENT-SPECIFIC CRANIAL IMPLANT GXN MEDCAD MC-SPK40 216439NOR 00810007630120

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Required Intervention