MAUDE Adverse Event Report: LONGEVITI NEURO SOLUTIONS CLEARFIT; CLEARFIT CRANIAL IMPLANT

Model Number	171713
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skull Fracture (2077)
Date of Event	09/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: CLEARFIT
• Common Device Name: CLEARFIT CRANIAL IMPLANT
• Manufacturer (Section D): LONGEVITI NEURO SOLUTIONS; 101 w dickman st; suite 600; baltimore MD 21230
• Manufacturer (Section G): LONGEVITI NEURO SOLUTIONS; 101 w dickman st; suite 600; baltimore MD 21230
• Manufacturer Contact: brooke lindsey ; 101 w dickman st; suite 600; baltimore, MD 21230 ; 3046412212
• MDR Report Key: 23395255
• Report Number: 3014680740-2025-00001
• Device Sequence Number: 10179299
• Product Code: PJN
• UDI-Device Identifier: 00855113008036
• UDI-Public: 00855113008036
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K210616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 171713
• Device Catalogue Number: 171713
• Device Lot Number: 3000967
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian