SpineMap Go 6002-690-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327412994), received between Dec 23, 2019 and Oct 23, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Imprecision” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2024Imprecision; Imprecision

  IT WAS REPORTED THAT DURING A CASE USING THE SPINEMAP GO SOFTWARE, THE SURGEON MISPLACED THE L4 AND L5 PEDICLE SCREWS WHICH RESULTED IN THE PATIENT EXPERIENCING DUROTOMIES AND NERVE INJURIES.

  Patient problems: Nerve Damage; Spinal Column Injury

  MAUDE report 20518375 ↗
• MalfunctionMay 24, 2021Imprecision; Intermittent Communication Failure; Imprecision; Intermittent Communication Failure

  IT WAS REPORTED THAT DURING A PRODUCT DEMONSTRATION AT THE USER FACILITY THE DEVICE WAS INACCURATE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING A PRODUCT DEMONSTRATION AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11869953 ↗
• MalfunctionMar 17, 2021Imprecision; Imprecision

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THERE WAS AN INACCURACY WHEN NAVIGATING A NEEDLE USING THE DEVICE'S SOFTWARE AND A SPINE MASK AS THE PATIENT TRACKER. K-WIRES WERE MISPLACED THROUGH THE PEDICLES DURING THE PROCEDURE AND NEEDED REPOSITIONING PRIOR TO SCREW IMPLANTATION. USE OF NAVIGATION WAS ABORTED AND THE PROCEDURE WAS COMPLETED USING FLUOROSCOPY EQUIPMENT FOR IMAGE GUIDANCE. 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 11504852 ↗
• MalfunctionDec 23, 2019Imprecision; Incorrect Measurement; Imprecision; Incorrect Measurement

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE SURGEON HAD THE INSTRUMENT TIP IN A FIXED POINT AND NOTICED THAT WHEN HIS TRAJECTORY WAS CHANGED, IT WOULD CHANGE THE POSITION OF THE INSTRUMENT TIP ON THE SCREEN EVEN THOUGH THE TIP OF THE INSTRUMENT WAS NOT MOVING FROM IT'S ORIGINAL POINT OF ENGAGEMENT. 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 9510739 ↗