N/A 6002-810-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07613327616118), received between Apr 2, 2025 and Sep 16, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Imprecision” (12 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

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Image Orientation Incorrect

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50785058 ↗
• MalfunctionMar 25, 2026Incorrect Measurement

  IT WAS REPORTED DURING A CASE USING THE SPINE GUIDANCE 5 SOFTWARE, THE SCREWS SHOWED ON NAVIGATION TO BE IN PLACE AND ON TRAJECTORY BUT WHEN XRAYS WERE TAKEN THE ENTIRE LEFT SIDE WAS MEDIAL, RIGHT SIDE SCREWS WERE FINE. NO SURGICAL DELAY OR ANY ADVERSE CONSEQUENCES WERE REPORTED AT INTAKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24686702 ↗
• MalfunctionFeb 12, 2026Imprecision

  IT WAS REPORTED THAT DURING A CASE USING THE SPINE GUIDANCE 5 SOFTWARE, AFTER THE LEFT L5 SCREW WAS PLACED, NEUROMONITORING INFORMED THE SURGEON THAT THE MOTORS DROPPED BY A SIGNIFICANT AMOUNT. THE SURGEON PROCEEDED TO REMOVE THE LEFT L5 SCREW AND PLACED A PEDICLE FINDER THROUGH THAT CANNULATED HOLE USING NAVIGATION AND IT WAS SHOWN THAT THE INSTRUMENT WAS THROUGH THE FOREMEN. THE SURGEON PROCEEDED TO DO A DECOMPRESSION AND CONTINUE WITH PLACING THE REMAINING SCREWS, USING ONLY THE INTRAOPERATIVE SCANS FOR THE REMAINING SCREWS. THE REMAINDER OF THE SCREWS WERE ACCURATE WHICH WAS CONFIRMED BY X-RAYS. THERE WERE NO ADVERSE CONSEQUENCES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324181 ↗
• MalfunctionFeb 12, 2026Imprecision; Program or Algorithm Execution Failure

  IT WAS REPORTED THAT DURING A CASE USING THE SPINE GUIDANCE 5 SOFTWARE, THE NAVIGATION PLAN DISPLAYED THE SCREW AT T3 DESPITE IT BEING AT T4. 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 24324055 ↗
• MalfunctionFeb 12, 2026Imprecision

  IT WAS REPORTED THAT DURING A CASE USING THE SPINE GUIDANCE 5 SOFTWARE, THE TRAJECTORY WAS DISPLAYING LATERAL AND DID NOT ALIGN WITH THE PRE-PLANNED SCREW. THE SCREW APPEARED LATERAL ON IMAGING AND THE SCREW AS REMOVED. THERE WERE NO ADVERSE CONSEQUENCES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF OVER 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24322643 ↗
• MalfunctionNov 6, 2025Imprecision; Imprecision

  IT WAS REPORTED THAT DURING A CASE USING THE SPINE GUIDANCE 5 SOFTWARE, THE SCREWS WERE MISPLACED AND REQUIRED AN IMMEDIATE REVISIONS AND THERE WAS ANTERIOR DISPLACEMENT OF THE ALIF CAGE. A NEW SCAN WAS PERFORMED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23493196 ↗
• MalfunctionOct 7, 2025Imprecision; Imprecision

  IT WAS REPORTED THAT DURING A CADAVER LAB USING THE SPINE GUIDANCE 5 SOFTWARE, THE NAVIGATED INSTRUMENTS WERE INACCURATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23240644 ↗
• MalfunctionSep 18, 2025Imprecision; Imprecision

  IT WAS REPORTED THAT DURING A CASE USING THE SPINE GUIDANCE SOFTWARE, THERE WERE INACCURACIES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES AND A SURGICAL DELAY OF LESS THAN 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23089093 ↗
• MalfunctionAug 15, 2025Imprecision; Imprecision

  IT WAS REPORTED THAT DURING A CASE USING THE SPINE GUIDANCE 5 SOFTWARE, WHEN MERGING THE VERTEBRAL LEVEL IT WAS COMPLETELY OFF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22820303 ↗
• MalfunctionAug 4, 2025Imprecision; Imprecision

  IT WAS REPORTED THAT DURING A CASE USING THE SPINE GUIDANCE 5 SOFTWARE THERE WAS AN INACCURACY OF 3.7 MILLIMETERS FROM THE DISTAL TIP OF THE POINTER TO THE FIDUCIAL SCREW. 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 22710196 ↗
• InjuryJun 9, 2025Imprecision; Imprecision

  IT WAS REPORTED THAT DURING A CASE USING THE SPINE GUIDANCE 5 SOFTWARE, THE SCREWS WERE MISPLACED CAUSING AN ANTERIOR BREACH. THERE WAS A SURGICAL DELAY OF OVER 120 MINUTES AND THE PATIENT EXPERIENCED BLEEDING AND BLOOD CLOTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Thrombosis/Thrombus

  MAUDE report 22171583 ↗
• MalfunctionApr 17, 2025Imprecision; Imprecision

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21858541 ↗
• MalfunctionApr 15, 2025Imprecision; Fail-Safe Did Not Operate; Imprecision; Fail-Safe Did Not Operate

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21840498 ↗
• MalfunctionApr 2, 2025Imprecision; Imprecision

  IT WAS REPORTED THAT DURING A CASE USING THE SPINE GUIDANCE 5 SOFTWARE, AN X-RAY DISPLAYED THAT THE SCREWS WERE MEDIAL AND BREACHED. THE SCREWS WERE REMOVED AND PLACED AGAIN USING NAVIGATION. THERE WERE NO ADVERSE CONSEQUENCES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21757860 ↗