ClearFit 171713Recalls & reported problems
Longeviti Neuro Solutions LLC · Extra Large Static Cranial Implant (Primary and Backup · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00855113008036), received between Oct 27, 2025 and Oct 27, 2025 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Skull Fracture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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.
Patient problems: Skull Fracture
MAUDE report 23395255 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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