BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUSHAPE

    MDR report key: 8376662 · Received February 27, 2019

    Report

    Report Number
    3009196021-2019-00003
    Event Type
    Injury
    Date Received
    February 27, 2019
    Date of Event
    November 13, 2018
    Report Date
    February 27, 2019
    Manufacturer
    MEDCAD
    Product Code
    GXN
    PMA / PMN Number
    K110684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT AND NOT FOR DIAGNOSIS. ON (B)(6) 2018, MEDCAD CONTACTED THE INITIAL REPORTER VIA EMAIL TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENTS DESCRIBED, INCLUDING THE PATIENT'S WEIGHT. THE INITIAL REPORTER STATED VIA EMAIL THAT THE INFECTION EXPERIENCED BY THE PATIENT WAS DUE TO A PREVIOUS INFECTION. ADDITIONAL ATTEMPTS WERE MADE TO REQUEST MORE INFORMATION ON JANUARY 4, 2019, AND AGAIN ON JANUARY 10, 2019. AS OF THE DATE OF THIS REPORT, MEDCAD HAS NOT RECEIVED A RESPONSE TO THESE REQUESTS. 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.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166379 ACCUSHAPE PEEK PATIENT-SPECIFIC IMPLANT GXN MEDCAD 183027 PHI

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention