BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUSHAPE

    MDR report key: 12674708 · Received October 21, 2021

    Report

    Report Number
    3009196021-2021-00006
    Event Type
    Injury
    Date Received
    October 21, 2021
    Report Date
    November 18, 2021
    Manufacturer
    MEDCAD
    Product Code
    GXN
    UDI-DI
    00810007630120
    PMA / PMN Number
    K110684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021 MEDCAD CONTACTED THE INITIAL REPORTER VIA EMAIL TO REQUEST ADDITIONAL INFORMATION ABOUT THE REPORTED EVENT. THE INFORMATION REQUESTED INCLUDED THE NATURE OF THE INFECTION THE PATIENT REPORTEDLY EXPERIENCED, ANY POTENTIAL CAUSES, AND THE DATE OF THE DEVICE EXPLANT. THE INITIAL REPORTER WAS CONTACTED BY PHONE ON (B)(6) 2021 AS A FOLLOW-UP TO THE PREVIOUS EMAIL. ON (B)(6) 2021, MEDCAD MADE A THIRD ATTEMPT TO CONTACT THE INITIAL REPORTER, AGAIN VIA EMAIL. NO RESPONSE WAS RECEIVED TO MEDCAD'S REQUESTS FOR ADDITIONAL INFORMATION. ON (B)(6) 2021 MEDCAD COMPLETED A REVIEW OF THE DEVICE HISTORY RECORD FOR THE SUSPECT DEVICE. INVESTIGATION INTO THE DEVICE HISTORY RECORD FOUND NO EVIDENCE OF NONCONFORMANCE WITH ANY ESTABLISHED PRODUCTION PROCESS. NO DEVICE PROBLEM WAS IDENTIFIED. THE INVESTIGATION DID NOT ESTABLISH A CAUSE FOR THE REPORTED INFECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED POST-OPERATIVELY WITH AN UNSPECIFIED INFECTION AND WOULD REQUIRE EXPLANTATION OF THE CRANIAL IMPLANT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED POST-OPERATIVELY WITH AN UNSPECIFIED INFECTION AND WOULD REQUIRE EXPLANTATION OF THE CRANIAL IMPLANT. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1575355 ACCUSHAPE PEEK PATIENT-SPECIFIC CRANIAL IMPLANT GXN MEDCAD MC-SPK40 215818ZOL 00810007630120

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Male Required Intervention