BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUSHAPE

    MDR report key: 9121017 · Received September 25, 2019

    Report

    Report Number
    3009196021-2019-00008
    Event Type
    Injury
    Date Received
    September 25, 2019
    Date of Event
    August 26, 2019
    Report Date
    September 25, 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. A REPLACEMENT ACCUSHAPE PEEK PATIENT-SPECIFIC CRANIAL IMPLANT WAS PROVIDED BY MEDCAD ON (B)(6) 2019. ON AUGUST 26, 2019, MEDCAD WAS INFORMED BY THE INITIAL REPORTER THAT THE ORIGINAL PATIENT-SPECIFIC CRANIAL IMPLANT HAD BEEN EXPLANTED AND THAT THE REPLACEMENT WAS IMPLANTED WITHOUT INCIDENT DURING THE SAME PROCEDURE. THE INITIAL REPORTER WAS UNABLE TO PROVIDE THE PATIENT'S WEIGHT AT THE TIME OF THE EVENT. ON SEPTEMBER 9, 2019, MEDCAD CONTACTED THE INITIAL REPORTER VIA EMAIL TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENTS DESCRIBED, INCLUDING A DESCRIPTION OF THE PATIENT HEALTH CONDITION THAT LED TO THE EXPLANT OF THE DEVICE. THE INITIAL REPORTER WAS UNABLE TO PROVIDE MEDCAD WITH ADDITIONAL DETAILS AS TO THE REASON FOR THE EXPLANT. UPON FOLLOW UP VIA EMAIL ON (B)(6) 2019, THE INITIAL REPORTER INFORMED MEDCAD, "I AM NOT SURE IF IT WAS INFECTION OR LACK OF TISSUE COVERAGE / HEALING THAT LED TO THE RE OPERATION. I KNOW THE SCALP WAS VERY THIN AND PROVIDED A COMPLEX CLOSURE OVER THE DEFECT." REVIEW OF PRODUCTION RECORDS FOUND THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH MEDCAD'S PRODUCTION REQUIREMENTS. NO NONCONFORMANCE WAS DETECTED THROUGHOUT THE PRODUCTION OF THE DEVICE. INVESTIGATION WAS UNABLE TO ESTABLISH A CAUSE FOR THE REPORTED EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2019, MEDCAD RECEIVED A SERVICE REQUEST FROM A DISTRIBUTOR SALES REPRESENTATIVE REQUESTING AN ACCUSHAPE PATIENT SPECIFIC CRANIAL IMPLANT (PSCI) FOR A PATIENT FOR WHOM MEDCAD HAD PREVIOUSLY PROVIDED AN ACCUSHAPE PSCI. THE SALES REPRESENTATIVE STATED THAT THE SKIN OVER THE IMPLANT WAS "BAD" AND NEEDED TO BE REPAIRED, AFTER USE OF A TISSUE EXPANDER. UPON FOLLOW UP WITH THE SALES REPRESENTATIVE ON (B)(6) 2019, MEDCAD WAS INFORMED THAT THE DEVICE IN QUESTION WAS EXPLANTED ON (B)(6) 2019. THE SALES REPRESENTATIVE WAS UNABLE TO CONFIRM TO MEDCAD THE CAUSE FOR EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909050 ACCUSHAPE PEEK PATIENT-SPECIFIC CRANIAL IMPLANT GXN MEDCAD 193301 VAR

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention