BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ANATOMICS STARPORE EAR IMPLANT

    MDR report key: 17447504 · Received August 2, 2023

    Report

    Report Number
    3007630408-2023-00011
    Event Type
    Malfunction
    Date Received
    August 2, 2023
    Date of Event
    June 2, 2023
    Report Date
    August 2, 2023
    Manufacturer
    ANATOMICS PTY LTD
    Product Code
    JOF
    PMA / PMN Number
    NANA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICES REQUIRE PATHOLOGY TESTINGS OR BE RETURNED TO MANUFACTURER TO AID WITH THE INVESTIGATION. IF ADDITIONAL INFORMATION IS RECEIVED FROM THE CUSTOMERS REGARDING THE EVENT, IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT. IMPLANTS' TRACEABILITY WERE CHECKED AND FOUND TO HAVE NO PROCESS NOR PRODUCT NON-CONFORMITIES. SAMPLES FROM UNUSED (STOCK-ON-HAND) SIMILAR IMPLANTS MANUFACTURED AT A SIMILAR TIME POINT USING THE SAME PROCESS AND MATERIALS AS THE IMPLANTS IN QUESTION WERE SENT FOR ROUTINE ANALYSES (ENDOTOXIN AND STERILITY TESTINGS). THE TESTINGS SHOW SATISFACTORY RESULTS AS FOLLOWS: ENDOTOXIN LEVEL: <5 EU/DEVICE (LIMIT: 20 EU/DEVICE); STERILITY: NO VISIBLE GROWTH OF MICROORGANISMS. CONCLUSION TO DATE: NO ANOMALIES FOUND ON THE DEVICES.

    Description of Event or Problem · 0

    SURGEON ADVISED TO EXPLANT AND REPLACE STARPORE EARS BECAUSE OF NON-SPECIFIC SWELLING. OTHER PATIENTS WHO HAVE COMPLETED EXPLANTATION HAVE MADE A SATISFACTORY RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1337544 ANATOMICS STARPORE EAR IMPLANT POLYMER, ENT SYNTHETIC, POROUS POLYETHYLENE JOF ANATOMICS PTY LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Required Intervention