N/A 6002-710-000Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · Spine Guidance Software · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker Spine Guidance Software is used to help surgeons place spine screws accurately during surgery. The 50 reports mostly describe the navigation being off by a few millimeters or otherwise inaccurate, so screws or guide wires ended up misplaced and surgeons had to redo steps or abandon navigation; most procedures were completed after short delays with no harm to the patient. No deaths or injuries were reported. There are no recalls naming 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
- 50
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 07613327545883), received between Sep 27, 2022 and Aug 7, 2025 — classified as 50 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (35 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
- Incorrect Measurement35
- Imprecision20
- Display or Visual Feedback Problem8
- Use of Device Problem4
- Intermittent Program or Algorithm Execution3
- No Device Output2
- Application Program Problem1
- Improper or Incorrect Procedure or Method1
Patient problems
- No Clinical Signs, Symptoms or Conditions48
- Insufficient Information7
Recent adverse event reports
The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2025Imprecision; Imprecision
IT WAS REPORTED THAT DURING A CASE USING THE SPINE GUIDANCE 4 SOFTWARE, THERE WAS AN REGISTRATION INACCURACY. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22737026 ↗MalfunctionMay 12, 2025Imprecision; Imprecision
IT WAS REPORTED THAT DURING A CASE USING THE SPINE GUIDANCE 4 SOFTWARE, THE ACCURACY WAS NOTICEABLY OFF WHEN PLACING THREE SCREWS. THERE WERE NO ADVERSE CONSEQUENCES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 5-10 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22005258 ↗MalfunctionMay 9, 2025Imprecision; Imprecision
IT WAS REPORTED THAT DURING A CASE USING THE SPINE GUIDANCE 4 SOFTWARE, NAVIGATION WAS FOUND TO BE INACCURATE AFTER PLACING TWO SCREWS ON THE PATIENT'S LEFT SIDE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 15-20 MINUTES AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21996977 ↗MalfunctionMay 1, 2025Imprecision; Imprecision
NO ADDITIONAL INFORMATION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21942187 ↗MalfunctionMar 21, 2025Imprecision; Imprecision
IT WAS REPORTED THAT DURING A CASE USING THE SPINE GUIDANCE 4 SOFTWARE, THREE SCREWS WERE PLACED INACCURATELY. NAVIGATION WAS ABORTED AND THE SURGEON PROCEEDED WITH THE CASE.
Patient problems: Insufficient Information
MAUDE report 21663382 ↗MalfunctionMar 21, 2025Imprecision; Imprecision
NO ADDITIONAL INFORMATION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21663378 ↗MalfunctionFeb 11, 2025Imprecision; Imprecision
IT WAS REPORTED THAT DURING A CASE USING THE SPINE GUIDANCE 4 SOFTWARE, THE NAVIGATION WAS INACCURATE WHICH RESULTED IN THE SURGEON MISPLACING THE GUIDE WIRE. THE SURGEON REDID THE GUIDE WIRE PLACEMENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 40 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21355847 ↗MalfunctionOct 29, 2024Imprecision; Imprecision
IT WAS REPORTED THAT DURING A CASE USING THE SPINE GUIDANCE SOFTWARE, THE ACCURACY WAS OFF BY A FEW MILLIMETERS WHEN PLACING A SCREW WITH THE DRIVER. THE DRIVER WAS THEN RECALIBRATED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20563389 ↗MalfunctionSep 26, 2024Imprecision; Imprecision
IT WAS REPORTED THAT DURING A CASE USING THE SPINE GUIDANCE SOFTWARE, THE ACCURACY WAS OFF BY 1 MILLIMETER. THEY THEN SUCCESSFULLY PERFORMED POINT-TO-POINT REGISTRATION TO REGAIN ACCURACY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20314892 ↗MalfunctionSep 13, 2024Display or Visual Feedback Problem; Imprecision; Display or Visual Feedback Problem; Imprecision
IT WAS REPORTED THAT DURING A CASE USING THE SPINE GUIDANCE SOFTWARE, THE DISPLAYED LOCATION OF THE INSTRUMENTS DURING NAVIGATION WAS INACCURATE. THE INSTRUMENTS WERE SHOWN TO BE MOVING UP AND DOWN ON THE PATIENT WHEN THE SURGEON WAS HOLDING IT STILL AND THERE WAS NO PATIENT MOVEMENT. THIS RESULTED IN CONTINUOUS INSTRUMENT RE-REGISTRATION AND A SURGICAL DELAY OF OVER 10 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20215024 ↗MalfunctionSep 11, 2024Imprecision; Imprecision
IT WAS REPORTED THAT DURING A CASE USING THE SPINE GUIDANCE SOFTWARE, THERE WAS AN INACCURACY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20193766 ↗MalfunctionSep 11, 2024Display or Visual Feedback Problem; Imprecision; Display or Visual Feedback Problem; Imprecision
IT WAS REPORTED THAT DURING A CASE USING THE SPINE GUIDANCE SOFTWARE, THE DISPLAYED LOCATION OF THE INSTRUMENTS DURING NAVIGATION WAS INACCURATE. THE INSTRUMENTS WERE SHOWN TO BE MOVING UP AND DOWN ON THE PATIENT WHEN THE SURGEON WAS HOLDING IT STILL AND THERE WAS NO PATIENT MOVEMENT. THIS RESULTED IN CONTINUOUS INSTRUMENT RE-REGISTRATION AND A SURGICAL DELAY OF ABOUT 10-15 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20193551 ↗MalfunctionAug 28, 2024Imprecision; Imprecision
IT WAS REPORTED THAT DURING A CASE WHEN USING THE SPINE GUIDANCE SOFTWARE, THE NAVIGATION WAS NOT DISPLAYING THE DISTAL TIP ON THE FIDUCIAL SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20091886 ↗MalfunctionAug 15, 2024Imprecision; Imprecision
IT WAS REPORTED THAT DURING A CASE USING THE SPINE GUIDANCE SOFTWARE, THE NAVIGATION WAS INACCURATE WHEN THE SURGEON WAS ATTEMPTING SCREW PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19994985 ↗MalfunctionJul 31, 2024Display or Visual Feedback Problem; Imprecision; Display or Visual Feedback Problem; Imprecision
IT WAS REPORTED THAT DURING A CASE USING THE SPINE GUIDANCE SOFTWARE, THE VIRTUAL TIP OF THE WOULD MOVE AROUND EVEN WHEN THE INSTRUMENT WAS HELD STILL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19876133 ↗MalfunctionJun 18, 2024Display or Visual Feedback Problem; Incorrect Measurement; Display or Visual Feedback Problem; Incorrect Measurement
WHEN USING THE SPINE GUIDANCE SOFTWARE DURING A CASE, THE VIRTUAL SCREW PROJECTION WAS SHOWING 5 MILLIMETERS AWAY FROM THEIR ACTUAL TRAJECTORY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19560315 ↗MalfunctionMay 29, 2024Imprecision; Incorrect Measurement; Imprecision; Incorrect Measurement
IT WAS REPORTED THAT DURING A CASE, THERE WERE INACCURACIES WHEN USING THE SPINE GUIDANCE SOFTWARE. THE NAVIGATED INSTRUMENTS WERE SHOWING 1 CENTIMETER TOO DEEP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19415697 ↗MalfunctionMar 4, 2024Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT IT WAS FOUND THAT THE ACCURACY WAS 4-5MM OFF FOR A TLIF PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18828485 ↗MalfunctionFeb 27, 2024Imprecision; Incorrect Measurement; Imprecision; Incorrect Measurement
IT WAS REPORTED THAT THE SPINE GUIDANCE SOFTWARE WAS INACCURATE DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18793714 ↗MalfunctionFeb 15, 2024Incorrect Measurement; Application Program Problem; Incorrect Measurement; Application Program Problem
IT WAS REPORTED THAT WHEN USING THE SPINE GUIDANCE SOFTWARE, THERE WERE INACCURACIES. THIS RESULTED IN A SURGICAL DELAY OF 45 MINUTES AND THE PATIENT WAS SUBJECTED TO LONGER ANESTHESIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18717278 ↗MalfunctionNov 27, 2023Imprecision; Incorrect Measurement; Imprecision; Incorrect Measurement
PER THE CUSTOMER, DURING A CASE WITH SPINE GUIDANCE SOFTWARE ON HE Q GUIDANCE SYSTEM, DURING SCREW PLACEMENT USING A MANUAL SCREWDRIVER WITH ROTATIONAL ADAPTER, THEY NOTICED THE TOOL MOVING ON THE SCREEN ABNORMALLY. 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 18208591 ↗MalfunctionNov 20, 2023Incorrect Measurement; Use of Device Problem; Incorrect Measurement; Use of Device Problem
IT WAS REPORTED THAT DURING A SURGERY THE USER COULD NOT REMOVE THE BACKBOARD FROM THE CT SCAN AND WASN'T ABLE TO VISUALIZE THE ANATOMICAL POINTS FOR REGISTRATION. THE CT SCAN WAS COMPLETED, HOWEVER; THE USER HAD TO USE A DIFFERENT NAVIGATION UNIT TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18170330 ↗MalfunctionOct 30, 2023Incorrect Measurement; Use of Device Problem; Incorrect Measurement; Use of Device Problem
IT WAS REPORTED THAT DURING A SURGERY THE USER COULD NOT REMOVE THE BACKBOARD FROM THE CT SCAN AND WASN'T ABLE TO VISUALIZE THE ANATOMICAL POINTS FOR REGISTRATION. THE CT SCAN WAS COMPLETED, HOWEVER; THE USER HAD TO USE A DIFFERENT NAVIGATION UNIT TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18030215 ↗MalfunctionOct 24, 2023Incorrect Measurement; Use of Device Problem; Incorrect Measurement; Use of Device Problem
PER THE CUSTOMER, IT WAS REPORTED THAT DURING A SURGERY THE USER COULD NOT REMOVE THE BACKBOARD FROM THE CT SCAN AND WASN'T ABLE TO VISUALIZE THE ANATOMICAL POINTS FOR REGISTRATION. SURFACE MATCHING WAS INACCURATE BY "~2CM ." THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17994382 ↗MalfunctionOct 16, 2023Incorrect Measurement; Use of Device Problem; Incorrect Measurement; Use of Device Problem
PER THE CUSTOMER, IT WAS REPORTED THAT DURING A SURGERY THE USER COULD NOT REMOVE THE BACKBOARD FROM THE CT SCAN AND WASN'T ABLE TO VISUALIZE THE ANATOMICAL POINTS FOR REGISTRATION. SURFACE MATCHING WAS INACCURATE BY "~2CM ." THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17939779 ↗
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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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