SmartFrame NGS-SM-01Recalls & reported problems
Clearpoint Neuro, Inc. · SMARTFrame Scalp Mount Base · Class 2
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 00850359007324), received between Jul 22, 2024 and Jul 22, 2024 — 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
- Intracranial Hemorrhage1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A BILATERAL RESPONSIVE NEUROSTIMULATION (RNS) LEAD IMPLANTATION PROCEDURE WAS PERFORMED USING THE CLEARPOINT SYSTEM AND ASSOCIATED ACCESSORIES FOR PLACEMENT OF THE RNS LEADS. WHEN REVIEWING THE MRI SCANS AFTER DRILLING TWO 14MM CRANIAL BURR HOLES AND MOUNTING THE SCALP MOUNT BASES ON EACH SIDE, A SUBDURAL BLEED WAS NOTED ON THE PATIENT'S RIGHT SIDE. THE PATIENT WAS THEN TRANSFERRED TO THE OPERATING ROOM AND THE PROCEDURE USING CLEARPOINT NEURO'S PRODUCTS WAS ABORTED. PER CONFIRMATION OF THE CLINICAL SPECIALIST SUPPORTING THIS PROCEDURE, THE BLEEDING WAS OBSERVED IN TWO LOCATIONS: 1) NEAR THE ANTERIOR BONE SCREW OF THE SCALP MOUNT BASE MOUNTED ON THE RIGHT SIDE, 2) NEAR THE POSTERIOR AND LATERAL SIDE OF THE RIGHT BURR HOLE. CLEARPOINT NEURO PRODUCTS WERE USED AS INTENDED THROUGHOUT THE PROCEDURE. AS OF (B)(6) 2024, THE SURGEON CONFIRMED THAT THE PATIENT IS DOING WELL AND IS EXPECTED TO BE DISCHARGED.
Patient problems: Intracranial Hemorrhage
MAUDE report 19794861 ↗
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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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