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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

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