BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSHAPE

    MDR report key: 8737659 · Received June 26, 2019

    Report

    Report Number
    3009196021-2019-00005
    Event Type
    Malfunction
    Date Received
    June 26, 2019
    Date of Event
    May 21, 2018
    Report Date
    June 24, 2019
    Manufacturer
    MEDCAD
    Product Code
    GXN
    PMA / PMN Number
    K110684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT AND NOT FOR DIAGNOSIS. ON (B)(6) 2018, A DISTRIBUTOR SALES REPRESENTATIVE INFORMED MEDCAD THAT THE ACCUSHAPE PATIENT-SPECIFIC IMPLANT DID NOT PROVIDE ADEQUATE DEFECT COVERAGE. ACCORDING TO THE COMPLAINANT, THERE WAS MORE RETRACTION IN THE TEMPORALIS REGION OF THE DEFECT THAN THE SURGEON HAD REQUESTED. REVIEW OF PRODUCTION RECORDS FOR THE CASE SHOW THAT UPON REVIEW OF THE IMPLANT DESIGN, THE SURGEON REQUESTED ADDITIONAL RETRACTION FROM THE PATIENT'S NATIVE BONE. REVIEW OF THE DESIGN FILE SHOWS THAT THE IMPLANT WAS REDESIGNED AND MANUFACTURED WITH MORE RETRACTION THAN THE SURGEON REQUESTED. ON (B)(6)2018, THE COMPLAINANT INFORMED MEDCAD THAT THE IMPLANT WAS NOT USED TO COMPLETE THE SURGERY ON (B)(6) 2018, DUE TO UNINTENDED FIT. ACCORDING TO THE COMPLAINANT, SURGERY WAS SUCCESSFULLY COMPLETED USING TITANIUM MESH INSTEAD OF THE ACCUSHAPE CRANIAL IMPLANT. IF ADDITIONAL INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    ON (B)(6) 2018, A DISTRIBUTOR SALES REPRESENTATIVE NOTIFIED MEDCAD THAT THE ACCUSHAPE PEEK PATIENT-SPECIFIC CRANIAL IMPLANT DID NOT PROVIDE ADEQUATE DEFECT COVERAGE. AS A RESULT, THE IMPLANT WAS NOT USED TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529448 ACCUSHAPE PEEK PATIENT-SPECIFIC IMPLANT GXN MEDCAD 182312 SIN

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR