SPINEMAP 6002-670-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327114898), received between May 25, 2018 and Jun 20, 2023 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Image Display Error/Artifact” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER WHILE NAVIGATING WITH THE DEVICE THE SURGEON COMPLAINED OF AN INACCURACY. PER THE SURGEON THE AWL¿S TIP AND KWIC NEEDLE SEEMED PUNCTURED IN BONE WHILE OTHERS POINTER DID NOT. 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 17165247 ↗
• MalfunctionNov 28, 2022Incorrect Measurement; Application Program Problem: Parameter Calculation Error; Incorrect Measurement; Application Program Problem: Parameter Calculation Error

  PER THE CUSTOMER, IT WAS REPORTED THAT THE NAVIGATION DEVICE WAS NOT COMPLETING THE SURFACE MATCH CORRECTLY WHICH COULD CAUSE AN INACCURACY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15868699 ↗
• MalfunctionMar 25, 2021Display or Visual Feedback Problem; Imprecision; Display or Visual Feedback Problem; Imprecision

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY WHEN TRYING TO DO AN ANATOMICAL REGISTRATION, THE POINT POSITION WAS NOT ACCURATE AND UNABLE TO BE REGISTERED. 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 11570149 ↗
• InjuryDec 16, 2020Imprecision; Imprecision

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE SURGEON USING THE SPINEMAP 3.0 SOFTWARE TO NAVIGATE FOR GUIDEWIRE PLACEMENT NOTED AN INACCURACY ISSUE WHEN ESTABLISHING PATIENT LANDMARKS, BUT PREFERRED MAKING REFERENCE TO MEDIAL-LATERAL COORDINATE WHILE USING THE DEVICE. AFTER PLACING THE GUIDEWIRES, THE SURGEON USED AN X-RAY SCAN AND FOUND THAT THE GUIDEWIRES WERE POSITIONED DIFFERENTLY THAN INTENDED. IT WAS REPORTED THE PATIENT NEEDED A BLOOD TRANSFUSION, EXPERIENCED A HEMATOMA, AND THAT THE SURGERY WAS DELAYED FOR ONE HOUR. DURING THE DELAY BETWEEN PROCEDURES, IT WAS REPORTED THE PATIENT'S BLOOD PRESSURE DROPPED. AN ADDITIONAL SURGERY WAS CONDUCTED TO RE-POSITION THE GUIDEWIRES USING X-RAY GUIDANCE FOR PLACEMENT AND TO TREAT THE HEMATOMA. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY, NO FURTHER ADVERSE EVENTS OR MEDICAL INTERVENTION HAS BEEN REPORTED.

  Patient problems: Hematoma; Neuropathy

  MAUDE report 11015475 ↗
• MalfunctionFeb 22, 2019Image Display Error/Artifact; Image Display Error/Artifact

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY THE DEVICE JUMPED LOCATION DISPLAYING AN IMPROPER LOCATION ON THE VISUAL DISPLAY USED FOR GUIDANCE. 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 8363789 ↗
• MalfunctionFeb 22, 2019Image Display Error/Artifact; Image Display Error/Artifact

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY THE DEVICE JUMPED LOCATION DISPLAYING AN IMPROPER LOCATION ON THE VISUAL DISPLAY USED FOR GUIDANCE. 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 8362690 ↗
• MalfunctionMay 25, 2018Image Orientation Incorrect; Image Orientation Incorrect

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY THE DEVICE LOST ACCURACY. 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 7544767 ↗