STRYKER NAV3I 7700-800-000Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · STRYKER NAV3I(TM) PLATFORM · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker Nav3i navigation platform helps surgeons guide instruments during procedures. The 42 reports mostly describe inaccurate navigation, display problems and poor image quality, with procedures completed without reported harm. There were no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 42
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 07613327004175), received between Feb 10, 2017 and Feb 27, 2026 — classified as 42 malfunctions.
The most frequently reported specific device problem is “Imprecision” (23 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.
Reports received per month
Most reported problems
Device problems
- Imprecision23
- Image Display Error/Artifact12
- Incorrect Measurement7
- Image Orientation Incorrect3
- Display or Visual Feedback Problem2
- Application Interface Becomes Non-Functional Or Program Exits Abnormally1
- Application Program Freezes or Fails to Launch1
- Device Handling Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- No Consequences Or Impact To Patient21
- Insufficient Information4
- No Patient Involvement3
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2026Imprecision
IT WAS REPORTED THAT DURING A CASE USING THE NAV3I, THE DEPTH DISPLAY CHANGED ON ITS OWN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24471815 ↗MalfunctionNov 5, 2024Imprecision; Imprecision
IT WAS REPORTED THAT DURING A CASE, THE NAVIGATION SYSTEM WAS INACCURATE AND THERE WERE POOR QUALITY IMAGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20609889 ↗MalfunctionAug 21, 2024Imprecision; Imprecision
IT WAS REPORTED THAT DURING A CASE USING THE NAV3I SOFTWARE, THERE WERE CONCERNS OF INACCURACY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20013822 ↗MalfunctionAug 17, 2024Imprecision; Imprecision
IT WAS REPORTED THAT DURING A CASE USING THE NAV3I SOFTWARE, THERE WERE CONCERNS OF INACCURACY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19998826 ↗MalfunctionAug 15, 2024Imprecision; Imprecision
IT WAS REPORTED THAT DURING A CASE USING THE NAV3I SOFTWARE, THERE WERE CONCERNS OF INACCURACY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19996156 ↗MalfunctionDec 4, 2023Imprecision; Incorrect Measurement; Imprecision; Incorrect Measurement
PER THE CUSTOMER, AUTOMATIC REGISTRATION NOT ACCURATE ON NAV3I WITH ZIEHM C ARM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18256406 ↗MalfunctionAug 15, 2023Erratic or Intermittent Display; Incorrect Measurement; Erratic or Intermittent Display; Incorrect Measurement
PER THE CUSTOMER, THE VIRTUAL TOOL TIP SCREW PROJECTION ONLY SHOWED ABOUT HALF THE LENGTH OF THE SCREW, THIS COULD LEAD TO INACCURACIES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17553706 ↗MalfunctionJul 27, 2022Incorrect Measurement; Incorrect Measurement
PER THE CUSTOMER, THE DEVICE WAS INACCURATE DURING A PROCEDURE. 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 15113609 ↗MalfunctionJul 27, 2022Incorrect Measurement; Incorrect Measurement
PER THE CUSTOMER, THE DEVICE WAS INACCURATE DURING A PROCEDURE. 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 15112999 ↗MalfunctionMay 16, 2022Display or Visual Feedback Problem; Imprecision; Incorrect Measurement; Display or Visual Feedback Problem; Imprecision; Incorrect Measurement
PER THE CUSTOMER, THE LIVE CAMERA FROZE DURING THE CASE AND WAS LAGGY WHICH COULD LEAD TO AN INACCURACY. 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 14412762 ↗MalfunctionJan 31, 2022Imprecision; Incorrect Measurement; Imprecision; Incorrect Measurement
PER THE CUSTOMER, DURING A CASE THE IMAGE GUIDED DEVICE HAD ISSUES WITH ACCURACY DURING THE CASE. THE DEVICE HAD TO BE REREGISTERED TO ATTAIN ACCURACY. 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 13392640 ↗MalfunctionDec 28, 2021Imprecision; Application Program Freezes or Fails to Launch; Imprecision; Application Program Freezes or Fails to Launch
IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE SYSTEM WAS LAGGING. THE SYSTEM ALSO SHUT DOWN DURING USE. 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 13093604 ↗MalfunctionApr 28, 2021Device Handling Problem; Intermittent Communication Failure; Device Handling Problem; Intermittent Communication Failure
IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY NAVIGATION EQUIPMENT WAS UNABLE TO BE REGISTERED AND ITS USE WAS CANCELED. THE DEVICE HAD ANOTHER PATIENT'S ANATOMY LOADED WHICH COULD CAUSE AN INACCURACY. 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 11738756 ↗MalfunctionApr 6, 2021Display or Visual Feedback Problem; Incorrect Measurement; Display or Visual Feedback Problem; Incorrect Measurement
IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY WHILE NAVIGATING AT C2 WITH THE DRILL GUIDE, WHEN TRYING TO POSITION CORRECTLY, THE IMAGE STARTED TO ROCK BACK AND FORTH WHILE THE INSTRUMENT WAS HELD STEADY. 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 11623131 ↗MalfunctionDec 16, 2020Imprecision; Imprecision
IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE DEVICE WAS INACCURATE. UPON FOLLOW UP, THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11015571 ↗MalfunctionDec 16, 2020Imprecision; Imprecision
IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE DEVICE WAS INACCURATE. THERE ARE NO FURTHER DETAILS CURRENTLY KNOWN, ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE USER FACILITY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11015477 ↗MalfunctionDec 16, 2020Imprecision; Imprecision
IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE DEVICE WAS INACCURATE. UPON FOLLOW UP, THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11015417 ↗MalfunctionDec 16, 2020Imprecision; Imprecision
IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE DEVICE WAS INACCURATE. UPON FOLLOW UP, THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11015408 ↗MalfunctionSep 3, 2020Imprecision; Imprecision
IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE DEVICE WAS INACCURATE BY OVER 2MM. 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; No Patient Involvement
MAUDE report 10491445 ↗MalfunctionJul 13, 2020Imprecision; Imprecision
IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE SYSTEM WAS INACCURATE. 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; No Consequences Or Impact To Patient
MAUDE report 10265222 ↗MalfunctionJul 6, 2020Imprecision; Imprecision
IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE AT THE USER FACILITY DURING AN ANATOMICAL REGISTRATION THE CUSTOMER WAS UNABLE TO ACHIEVE ACCURATE REGISTRATION OF THE PATIENT LANDMARKS AND WAS UNABLE TO PROCEED WITH USING THE DEVICE FOR THE PROCEDURE. THE LANDMARKS ENSURE ACCURACY OF THE DEVICE DURING THE PROCEDURE. 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; No Consequences Or Impact To Patient
MAUDE report 10233700 ↗MalfunctionJul 6, 2020Imprecision; Imprecision
IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE AT THE USER FACILITY DURING AN ANATOMICAL REGISTRATION THE CUSTOMER WAS UNABLE TO ACHIEVE ACCURATE REGISTRATION OF THE PATIENT LANDMARKS AND WAS UNABLE TO PROCEED WITH USING THE DEVICE FOR THE PROCEDURE. THE LANDMARKS ENSURE ACCURACY OF THE DEVICE DURING THE PROCEDURE. 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; No Consequences Or Impact To Patient
MAUDE report 10233695 ↗MalfunctionJun 23, 2020Imprecision; Imprecision
IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE AT THE USER FACILITY DURING AN ANATOMICAL REGISTRATION THE CUSTOMER WAS UNABLE TO ACHIEVE ACCURATE REGISTRATION OF THE PATIENT LANDMARKS AND WAS UNABLE TO PROCEED WITH USING THE DEVICE FOR THE PROCEDURE. THE LANDMARKS ENSURE ACCURACY OF THE DEVICE DURING THE PROCEDURE. 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; No Consequences Or Impact To Patient
MAUDE report 10185695 ↗MalfunctionMar 12, 2020Imprecision; Loss of Data; Imprecision; Loss of Data
IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE DEVICE WAS INACCURATE DURING A PROCEDURE LEADING TO INCORRECT SCREW PLACEMENT. THE SCREWS WERE REPLACED DURING THE SURGERY TO COMPLETE THE PROCEDURE. 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; No Consequences Or Impact To Patient
MAUDE report 9823812 ↗MalfunctionJan 2, 2020Imprecision; Imprecision
IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE DEVICE WAS INACCURATE BY 5MM. 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; No Consequences Or Impact To Patient
MAUDE report 9538322 ↗
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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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