NaviNetics Reusable Stereotactic System NN1000Recalls & reported problems
Navinetics, Inc. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10850023620078), received between Nov 8, 2022 and Jan 25, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
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
- Device Dislodged or Dislocated1
- Improper or Incorrect Procedure or Method1
- Malposition of Device1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 25, 2024Improper or Incorrect Procedure or Method; Malposition of Device; Improper or Incorrect Procedure or Method; Malposition of Device
A COMPANY REPRESENTATIVE BECAME AWARE OF DBS LEAD IMPLANTATION PROCEDURE USING THE NAVINETICS STEREOTACTIC SYSTEM WHERE ONE OF THE TWO IMPLANTED LEADS WAS REPORTED OVER 2MM FROM THE PLANNED TARGET, THE OTHER LEAD WAS ACCURATELY POSITIONED UNDER 2MM. THE USER STATED OVERALL POSITIVE CLINICAL OUTCOMES AND NO INTENTION TO READJUST THE LEAD PLACEMENT, AND NO REPORTED ADVERSE EFFECTS EXPERIENCED BY THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18580727 ↗MalfunctionNov 8, 2022Use of Device Problem; Device Dislodged or Dislocated; Use of Device Problem; Device Dislodged or Dislocated
IN THE INITIAL REPORT NAVINETICS BECAME AWARE OF A CASE WITH >2MM PERFORMANCE ERROR, AND MOVEMENT OF THE SKULL ANCHOR KEY SCREWS. WHILE NO ADVERSE EVENTS WERE OBSERVED IN THIS CASE. AN INVESTIGATION WAS CONDUCTED AND DETERMINED THE CAUSE OF THE MALFUNCTION WAS A DEVIATION IN THE INSTRUCTIONS FOR SKULL ANCHOR KEY APPLICATION RESULTING IN INSUFFICIENT SECUREMENT, MOVEMENT OF THE SKULL ANCHOR KEY AND SUBSEQUENT TARGET INACCURACY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15753351 ↗
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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 13, 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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