BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUSHAPE

    MDR report key: 9548880 · Received January 3, 2020

    Report

    Report Number
    3009196021-2020-00002
    Event Type
    Injury
    Date Received
    January 3, 2020
    Date of Event
    June 1, 2018
    Report Date
    January 31, 2020
    Manufacturer
    MEDCAD
    Product Code
    GXN
    PMA / PMN Number
    K110684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE SURGEON, THE DEVICE WAS EXPLANTED APPROXIMATELY 7 MONTHS AFTER IT WAS IMPLANTED. THE DEVICE IN QUESTION WAS USED FOR TREATMENT AND NOT FOR DIAGNOSIS. THE DEVICE WAS IMPLANTED ON (B)(6) 2017, HOWEVER, THE SURGEON WAS UNABLE TO DETERMINE THE EXACT DATE. REVIEW OF THE DEVICE HISTORY RECORD FOR THE DEVICE FOUND THAT THE DEVICE WAS PRODUCED IN ACCORDANCE WITH MEDCAD'S PRODUCTION REQUIREMENTS. NO NONCONFORMANCE WAS IDENTIFIED DURING PRODUCTION. COMMUNICATION WITH THE SURGEON ON (B)(6) 2019, REVEALED THAT THE DEVICE WAS EXPLANTED AFTER THE PATIENT DEVELOPED AN INFECTION. ACCORDING TO THE SURGEON, THE INFECTION WAS CAUSED BY THE PATIENT "PICKING" AT THE INCISION SITE. ACCORDING TO COMMUNICATION WITH THE SURGEON, THE DEVICE WAS EXPLANTED ON (B)(6) 2018, HOWEVER THE EXACT DATE COULD NOT BE DETERMINED. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE CAUSE OF THE PATIENT INFECTION COULD NOT BE VERIFIED. MEDCAD CONTACTED THE DISTRIBUTOR SALES REPRESENTATIVE VIA EMAIL ON (B)(6) 2019, TO REQUEST ADDITIONAL INFORMATION FROM THE SURGEON, INCLUDING THE PATIENT'S WEIGHT AT THE TIME OF THE EVENT. AN ADDITIONAL FOLLOW-UP PHONE CALL TO OBTAIN THIS INFORMATION WAS MADE TO THE DISTRIBUTOR SALES REPRESENTATIVE ON JANUARY 8, 2020. AFTER MULTIPLE ATTEMPTS, MEDCAD WAS UNABLE TO OBTAIN THE PATIENT'S WEIGHT AT THE TIME OF THE EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THROUGH INTERNAL REVIEW OF HISTORICAL CASES, MEDCAD DISCOVERED THAT APPROXIMATELY 15 MONTHS AFTER PROVIDING AN ACCUSHAPE PATIENT-SPECIFIC CRANIAL IMPLANT (PSCI) FOR THE PATIENT, A SECOND IMPLANT WAS PROVIDED FOR THE SAME PATIENT WITH THE SAME DEFECT, INDICATING THAT THE PREVIOUS ACCUSHAPE PSCI WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11702 ACCUSHAPE PEEK PATIENT-SPECIFIC CRANIAL IMPLANT GXN MEDCAD 172036 MAS

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention