BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUSHAPE

    MDR report key: 8376475 · Received February 27, 2019

    Report

    Report Number
    3009196021-2019-00002
    Event Type
    Injury
    Date Received
    February 27, 2019
    Date of Event
    January 1, 2018
    Report Date
    February 27, 2019
    Manufacturer
    MEDCAD
    Product Code
    GXN
    PMA / PMN Number
    K110684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT AND NOT FOR DIAGNOSIS. ON MARCH 29, 2018, MEDCAD ATTEMPTED TO CONTACT THE INITIAL REPORTER VIA PHONE CALL TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENTS DESCRIBED, INCLUDING THE DATE OF THE EVENT, THE STATUS OF THE DEVICE, AND THE PATIENT'S WEIGHT. ADDITIONAL ATTEMPTS WERE MADE TO REQUEST THIS INFORMATION VIA EMAIL ON MARCH 29, 2018, AS WELL AS ON APRIL 5, 2018, AND ON APRIL 18, 2018. AS OF THE DATE OF THIS REPORT, MEDCAD HAS NOT RECEIVED A RESPONSE TO THESE REQUESTS. THE EXACT DATE OF THE REPORTED EVENT IS UNKNOWN. REVIEW OF PRODUCTION RECORDS FOUND THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH MEDCAD'S PRODUCTION REQUIREMENTS. NO NONCONFORMITIES WERE IDENTIFIED DURING THE PRODUCTION OF THE DEVICE. INVESTIGATION WAS UNABLE TO IDENTIFY ANY PROBLEMS WITH THE DEVICE. INVESTIGATION WAS UNABLE TO DETERMINE A CAUSE FOR THE REPORTED EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2018, A DISTRIBUTOR SALES REPRESENTATIVE NOTIFIED MEDCAD THAT AN ACCUSHAPE PEEK PATIENT-SPECIFIC CRANIAL IMPLANT WAS EXPLANTED FROM THE PATIENT AFTER THE PATIENT EXPERIENCED INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168460 ACCUSHAPE PEEK PATIENT-SPECIFIC IMPLANT GXN MEDCAD 171994 SWA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention