BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEARFIT

    MDR report key: 23395255 · Received October 27, 2025

    Report

    Report Number
    3014680740-2025-00001
    Event Type
    Injury
    Date Received
    October 27, 2025
    Date of Event
    September 27, 2025
    Report Date
    October 27, 2025
    Manufacturer
    LONGEVITI NEURO SOLUTIONS
    Product Code
    PJN
    UDI-DI
    00855113008036
    PMA / PMN Number
    K210616
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON INITIAL FINDINGS, LONGEVITI HAS CONCLUDED THAT THEIR MEDICAL DEVICE DID NOT CAUSE OR WORSEN THE TRAUMATIC SITUATION. LONGEVITI HAS DETERMINED THE CAUSE OF FAILURE TO BE DIRECT IMPACT ON THE IMPLANT WITH FORCE THAT EXCEEDS THE THRESHOLD OF FAILURE FOR THE HUMAN SKULL.

    Description of Event or Problem · 0

    THE PATIENT WAS INVOLVED IN A TRAUMATIC ACCIDENT, WHILE RIDING AN ELECTRIC SCOOTER, AND THE CRANIAL IMPLANT BROKE. THE PATIENT HAS A HISTORY OF SEIZURES LEADING THE SURGEON TO INFER THAT "THE SITUATION WAS MOST LIKELY CAUSED BY A SEIZURE WHILE [PERFORMING THE ACTIVITY]" EXACERBATING THE INJURY WAS A DECISION BY THE PATIENT TO NOT WEAR A PROTECTIVE HELMET. THE PATIENT CHOSE TO PERFORM THE ACTIVITY WITHOUT HEAD PROTECTION UNDERSTANDING THEY'VE HAD MULTIPLE SURGERIES AND A HISTORY OF SEIZURES. A SURGERY OCCURRED ON SATURDAY MORNING (B)(6) 2025. THROUGH PROCESS OF ELIMINATION, WHEREAS NO VISIBLE INJURIES OUTSIDE OF SURGICAL SITE WERE NOTED, IT WAS CONCLUDED BY THE SURGEON THAT, "THE POINT OF IMPACT WAS DIRECTLY ON (THE PORTION OF THE HEAD CONTAINING) THE IMPLANTED MEDICAL DEVICE." THE HOSPITAL HAS BEFORE AND AFTER CT SCANS OF THE INJURY. THE SURGEON PERFORMED A COMPLETE REMOVAL OF THE CLEARFIT (B)(6). THE SURGEON BELIEVED THE MEDICAL DEVICE BEHAVED AS IT SHOULD HAVE AND COULD HAVE BEEN WORSE WITHOUT THE DEVICE'S PROTECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2793937 CLEARFIT CLEARFIT CRANIAL IMPLANT PJN LONGEVITI NEURO SOLUTIONS 171713 3000967 00855113008036

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H