STRYKER NAV3 7700-700-000Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · Stryker NAV3(R) PLATFORM · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540696427), received between Apr 24, 2019 and Apr 25, 2022 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Imprecision” (3 reports).
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.
Most reported problems
Device problems
- Imprecision3
- Image Display Error/Artifact2
- Incorrect Measurement2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 25, 2022Imprecision; Incorrect Measurement; Imprecision; Incorrect Measurement
PER THE CUSTOMER THE DEVICE WILL NOT ALLOW ALTERATION DURING CASE AND SHOWING INACCURACIES AS THE POST TERROIR SHIFT HAPPENED AUTOMATICALLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14192937 ↗MalfunctionApr 22, 2022Imprecision; Incorrect Measurement; Imprecision; Incorrect Measurement
PER THE CUSTOMER THE DEVICE WILL NOT ALLOW ALTERATION DURING CASE AND SHOWING INACCURACIES AS THE POST TERRIOR SHIFT HAPPENED AUTOMATICALLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14190268 ↗MalfunctionSep 17, 2019Image Display Error/Artifact; Imprecision; Image Display Error/Artifact; Imprecision
IT WAS REPORTED THAT THE DEVICE'S CAMERA WAS INACCURATE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES; THERE WERE NO SIGNIFICANT PROCEDURE DELAYS; THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9077661 ↗MalfunctionApr 24, 2019Image Display Error/Artifact; Image Display Error/Artifact
IT WAS REPORTED THAT THE NAVIGATION SYSTEM WAS UNABLE TO LOAD IMAGES CORRECTLY DURING PREPARATION FOR A CRANIAL PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8544461 ↗
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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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