LEKSELL FRAME ADAPTOR 174017-01Recalls & reported problems
Medtech · "LEKSELL FRAME ADAPTOR instrument Rosa One 3.1 (brain application) Mechanical adaptor to connect the support arm to the leksell stereotactic frame, supplied with 8 mm hexagonal key" · Class 2
Data updated Oct 18, 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 03760244033598), received between Dec 29, 2023 and Dec 29, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Positioning Problem” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Positioning Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 29, 2023Positioning Problem; Positioning Problem
IT WAS REPORTED THAT AWAKE DBS PROCEDURE USING THE ROSA ROBOT WAS FORCED TO BE ABORTED DUE TO INACCURACY OF STEREOTACTIC GUIDANCE. DURING AWAKE TESTING, SURGICAL TEAM WAS NOT ABLE TO FIND DESIRED RESULTS OF STIMULATION AND CAME TO THE CONCLUSION SOME VARIABLE FORCED THE INACCURACY OF THE ROBOTIC ARM. NO PERMANENT ELECTRODES WERE LEFT IMPLANTED IN THE PATIENT AND THE PATIENT WAS NOT HARMED DUE TO THE INACCURACY. THIS CAUSED A TWO (2) HOUR DELAY AND THE PROCEDURE WILL BE RESCHEDULED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18417989 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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