BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUSHAPE

    MDR report key: 8161722 · Received December 13, 2018

    Report

    Report Number
    3009196021-2018-00003
    Event Type
    Injury
    Date Received
    December 13, 2018
    Date of Event
    November 1, 2018
    Report Date
    January 31, 2019
    Manufacturer
    MEDCAD
    Product Code
    GXN
    PMA / PMN Number
    K110684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS USED FOR TREATMENT AND NOT FOR DIAGNOSIS. ON DECEMBER 4, 2018, MEDCAD ATTEMPTED TO CONTACT THE INITIAL REPORTER VIA EMAIL TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENTS DESCRIBED, INCLUDING THE DATE OF THE EVENT, THE NATURE AND DETAILS OF THE EVENT, AND THE PATIENT'S WEIGHT. THERE HAS BEEN NO RESPONSE TO THIS REQUEST. ON DECEMBER 11, 2018, THE INTIAL REPORTER WAS TELEPHONED TO ATTEMPT TO COLLECT THIS INFORMATION. THE PHONE CALL HAS NOT BEEN RETURNED. ON JANUARY 10, 2019, MEDCAD AGAIN ATTEMPTED TO CONTACT THE INITIAL REPORTER VIA EMAIL. THERE HAS BEEN NO RESPONSE TO THIS ATTEMPT. MEDCAD WAS UNABLE TO DETERMINE THE DATE OF THE REPORTED EVENT, ANY FURTHER DETAILS OF THE EVENT, OR THE PATIENT'S WEIGHT. REVIEW OF THE PRODUCTION RECORDS FOUND THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH MEDCAD'S PRODUCTION REQUIREMENTS. NO NONCONFORMANCE RELATED TO THE PRODUCTION OF THE DEVICE WAS OBSERVED. INVESTIGATION WAS UNABLE TO IDENTIFY ANY PROBLEMS WITH THE DEVICE. INVESTIGATION WAS UNABLE TO DETERMINE A CAUSE FOR THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THE SPECIFIC DATE OF IMPLANTATION US UNKNOWN. THE DATE OF EXPLANT IS UNKNOWN, THOUGH THE DISTRIBUTOR SALES REPRESENTATIVE REPORTED ON NOVEMBER 27, 2018, THAT THE DEVICE WAS EXPLANTED THE DAY AFTER IMPLANTATION. EVALUATION FOR THIS EVENT IS STILL IN PROGRESS. A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE ONCE EVALUATION IS COMPLETE OR IF ADDITIONAL INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT.

    Description of Event or Problem · 1

    ON NOVEMBER 27, 2018, MEDCAD WAS NOTIFIED BY DISTRIBUTOR SALES REPRESENTATIVE THAT THE ACCUSHAPE PATIENT-SPECIFIC CRANIAL IMPLANT WAS EXPLANTED FROM THE PATIENT THE DAY AFTER IMPLANTATION. THE COMPLAINANT REPORTED THAT THE PATIENT EXPERIENCED AN INCREASE IN INTRACRANIAL PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998483 ACCUSHAPE PEEK PATIENT-SPECIFIC IMPLANT GXN MEDCAD 183079 TSA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention