NGENIUS 6000-014-000Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · NGENIUS UNIVERSAL TRACKER · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04546540651563), received between Feb 7, 2017 and Mar 1, 2024 — classified as 16 malfunctions.
The most frequently reported specific device problem is “Image Display Error/Artifact” (8 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Image Display Error/Artifact8
- Imprecision5
- Loose or Intermittent Connection5
- Incorrect Measurement4
- Detachment of Device or Device Component1
- Disassembly1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- No Patient Involvement5
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 1, 2024Incorrect Measurement; Detachment of Device or Device Component; Incorrect Measurement; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A CASE, THE NGENIUS UNIVERSAL TRACKER WAS NOT FULLY SEATED WHICH CAUSED THE ACCURACY TO BE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18821744 ↗MalfunctionNov 10, 2023Incorrect Measurement; Incorrect Measurement
PER THE CUSTOMER, THE DEVICE WAS INACCURATE AND NOT TRACKING. 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 18115143 ↗MalfunctionJul 25, 2022Incorrect Measurement; Incorrect Measurement
PER THE CUSTOMER THE DEVICE WAS FOUND TO BE LOOSE WHICH COULD LEAD TO A POTENTIAL 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 15093547 ↗MalfunctionJun 27, 2022Imprecision; Incorrect Measurement; Imprecision; Incorrect Measurement
PER THE CUSTOMER, THERE WAS A LOSS OF ACCURACY DURING THE IMAGE GUIDED 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 14827714 ↗MalfunctionDec 21, 2021Imprecision; Imprecision
IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE TRACKER WAS INACCURATE DURING A CASE. 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 13056236 ↗MalfunctionSep 13, 2021Imprecision; Imprecision
IT WAS REPORTED THAT DURING TESTING PRIOR TO A PROCEDURE AT THE USER FACILITY IT WAS OBSERVED THAT THE TRACKER INTERFACE IS LOOSE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12461515 ↗MalfunctionDec 18, 2020Imprecision; Imprecision
IT WAS REPORTED THAT DURING TESTING PRIOR TO A PROCEDURE AT THE USER FACILITY 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 11039449 ↗MalfunctionSep 20, 2019Image Display Error/Artifact; Loose or Intermittent Connection; Image Display Error/Artifact; Loose or Intermittent Connection
IT WAS REPORTED THAT IT WAS OBSERVED DURING A PREVENTATIVE MAINTENANCE VISIT THAT THE BASE OF THE DEVICE IS LOOSE WHICH COULD CAUSE INACCURACIES. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING ROUTINE MAINTENANCE VISIT AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.
Patient problems: No Patient Involvement
MAUDE report 9098108 ↗MalfunctionSep 20, 2019Image Display Error/Artifact; Loose or Intermittent Connection; Image Display Error/Artifact; Loose or Intermittent Connection
IT WAS REPORTED THAT IT WAS OBSERVED DURING A PREVENTATIVE MAINTENANCE VISIT THAT THE BASE OF THE DEVICE IS LOOSE WHICH COULD CAUSE INACCURACIES. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING ROUTINE MAINTENANCE VISIT AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.
Patient problems: No Patient Involvement
MAUDE report 9098107 ↗MalfunctionSep 20, 2019Image Display Error/Artifact; Loose or Intermittent Connection; Image Display Error/Artifact; Loose or Intermittent Connection
IT WAS REPORTED THAT IT WAS OBSERVED DURING A PREVENTATIVE MAINTENANCE VISIT THAT THE BASE OF THE DEVICE IS LOOSE WHICH COULD CAUSE INACCURACIES. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING ROUTINE MAINTENANCE VISIT AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.
Patient problems: No Patient Involvement
MAUDE report 9098104 ↗MalfunctionSep 20, 2019Image Display Error/Artifact; Loose or Intermittent Connection; Image Display Error/Artifact; Loose or Intermittent Connection
IT WAS REPORTED THAT IT WAS OBSERVED DURING A PREVENTATIVE MAINTENANCE VISIT THAT THE BASE OF THE DEVICE IS LOOSE WHICH COULD CAUSE INACCURACIES. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING ROUTINE MAINTENANCE VISIT AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.
Patient problems: No Patient Involvement
MAUDE report 9098039 ↗MalfunctionSep 20, 2019Image Display Error/Artifact; Loose or Intermittent Connection; Image Display Error/Artifact; Loose or Intermittent Connection
IT WAS REPORTED THAT IT WAS OBSERVED DURING A PREVENTATIVE MAINTENANCE VISIT THAT THE BASE OF THE DEVICE IS LOOSE WHICH COULD CAUSE INACCURACIES. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING ROUTINE MAINTENANCE VISIT AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.
Patient problems: No Patient Involvement
MAUDE report 9098033 ↗MalfunctionDec 18, 2018Image Display Error/Artifact; Image Display Error/Artifact
IT WAS REPORTED THAT THE ACCURACY OF THE DEVICE WAS FOUND TO BE OFF DURING A 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 8175235 ↗MalfunctionNov 26, 2018Image Display Error/Artifact; Image Display Error/Artifact
IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE AT THE USER FACILITY THE METAL PIECE THAT THE TRACKER CONNECTS TO THE INSTRUMENTATION IS LOOSE, 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 Consequences Or Impact To Patient
MAUDE report 8102697 ↗MalfunctionJul 2, 2018Image Display Error/Artifact; Image Display Error/Artifact
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY THE DEVICE WAS INACCURATE. 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 7654374 ↗MalfunctionFeb 7, 2017Disassembly; Imprecision; Disassembly; Imprecision
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE CONDUCTED AT THE USER FACILITY THE LED INTERFACE HAD LOOSENED CAUSING THE NAVIGATION TO BE INACCURATE. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED OR PROCEDURAL DELAYS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6306679 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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