BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUSHAPE

    MDR report key: 8497156 · Received April 9, 2019

    Report

    Report Number
    3009196021-2019-00004
    Event Type
    Injury
    Date Received
    April 9, 2019
    Date of Event
    March 10, 2019
    Report Date
    April 9, 2019
    Manufacturer
    MEDCAD
    Product Code
    GXN
    PMA / PMN Number
    K110684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT AND NOT FOR DIAGNOSIS. ON (B)(6) 2019, MEDCAD CONTACTED THE INITIAL REPORTER VIA EMAIL REQUESTING ADDITIONAL INFORMATION ABOUT THE EVENTS DESCRIBED, INCLUDING A REQUEST FOR THE PATIENT'S WEIGHT. THE INITIAL REPORTER COMMUNICATED VIA PHONE THAT THE DEVICE WAS IMPLANTED ON (B)(6) 2018 AND EXPLANTED ON (B)(6) 2019. THE OPERATING SURGEON COMMUNICATED VIA EMAIL THAT THE PATIENT HAD A HISTORY OF PRIOR INFECTION, AND THAT THE IMPLANT WAS REMOVED FOLLOWING EROSION THAT THE PATIENT EXPERIENCED AWAY FROM ANY PROMINENCE IN THE CRANIOPLASTY PLATE. THE SURGEON COMMUNICATED THAT HE DOES NOT BELIEVE THAT THE IMPLANT IS THE CAUSE FOR THE CONDITIONS EXPERIENCED BY THE PATIENT. REVIEW OF PRODUCTION RECORDS SHOWED THAT THE DEVICE WAS MANUFACTURED IN CONFORMANCE WITH INTERNAL REQUIREMENTS. NO NONCONFORMANCE WAS IDENTIFIED DURING PRODUCTION OF THIS IMPLANT. INVESTIGATION DID NOT IDENTIFY ANY DEVICE-RELATED PROBLEMS. AFTER REQUESTS FROM MEDCAD ON MARCH 11, 2019 AND (B)(6) 2019, THE INITIAL REPORTER WAS UNABLE TO PROVIDE THE PATIENT'S WEIGHT.

    Description of Event or Problem · 1

    ON MARCH 11, 2019, A DISTRIBUTOR SALES REPRESENTATIVE NOTIFIED MEDCAD THAT THE ACCUSHAPE PEEK PATIENT-SPECIFIC CRANIAL IMPLANT WAS REMOVED FROM THE PATIENT ON (B)(6) 2019, AFTER THE PATIENT EXPERIENCED AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290391 ACCUSHAPE PEEK PATIENT-SPECIFIC IMPLANT GXN MEDCAD 182952 WAR

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention