BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUSHAPE

    MDR report key: 13358309 · Received January 26, 2022

    Report

    Report Number
    3009196021-2022-00001
    Event Type
    Injury
    Date Received
    January 26, 2022
    Date of Event
    January 4, 2022
    Report Date
    February 15, 2022
    Manufacturer
    MEDCAD
    Product Code
    GXN
    UDI-DI
    0081007630106
    PMA / PMN Number
    K110684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2022, MEDCAD CONTACTED THE INITIAL REPORTER VIA EMAIL TO REQUEST ADDITIONAL INFORMATION ABOUT THE REPORTED EVENT. THE INFORMATION REQUESTED INCLUDED THE NATURE OF THE INFECTION EXPERIENCED BY THE PATIENT, ANY POTENTIAL CAUSES OR CONTRIBUTING FACTORS, AND THE WEIGHT OF THE PATIENT AT THE TIME OF THE EVENT. ON (B)(6) 2022, MEDCAD RECEIVED A RESPONSE; HOWEVER, THE COMPLAINANT WAS NOT ABLE TO PROVIDED THE REQUESTED INFORMATION. ON FEBRUARY 14, 2022, MEDCAD COMPLETED A REVIEW OF THE DEVICE HISTORY RECORD FOR THE SUSPECT DEVICES (SEE ALSO REPORT NUMBER 3009196021-2022-00002). INVESTIGATION INTO THE DEVICE HISTORY RECORD FOUND THAT THE DEVICES IN QUESTION WERE PRODUCED IN ACCORDANCE WITH ALL REQUIRED PRODUCTION STANDARDS. NO NONCONFORMANCE WAS IDENTIFIED THROUGHOUT THE PRODUCTION OF THE DEVICES IN QUESTION. NO DEVICE PROBLEM WAS IDENTIFIED THROUGH INVESTIGATION. THE INVESTIGATION DID NOT ESTABLISH A CAUSE FOR THE REPORTED INFECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CRANIAL IMPLANTS WERE EXPLANTED AFTER THE PATIENT EXPERIENCED AN INFECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CRANIAL IMPLANTS WERE EXPLANTED AFTER THE PATIENT EXPERIENCED AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692880 ACCUSHAPE PEEK PATIENT-SPECIFIC CRANIAL IMPLANT GXN MEDCAD 216153MOO 0081007630106

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female Required Intervention