SPINEMAP 6002-680-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 07613327359954), received between Jan 2, 2019 and Nov 5, 2024 — classified as 3 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Imprecision” (27 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 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2024Imprecision; Imprecision

  IT WAS REPORTED THAT DURING A CASE, THE NAVIGATION SYSTEM PRODUCED POOR QUALITY IMAGES THAT WERE UNABLE TO BE USED FOR SCREW PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20609983 ↗
• MalfunctionSep 4, 2024Imprecision; Imprecision

  IT WAS REPORTED THAT DURING A CASE USING THE SPINE MAP 3D 3.1 SOFTWARE, THE NAVIGATION WAS INACCURATE BY ABOUT 4-5 MILLIMETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20140367 ↗
• MalfunctionAug 29, 2024Imprecision; Imprecision

  IT WAS REPORTED THAT DURING A CASE USING THE SPINE MAP 3D 3.1 SOFTWARE, THE NAVIGATED GUIDE WAS INACCURATE WHICH RESULTED IN INCORRECT SCREW PLACEMENTS. THE SURGEON REPLACED 6 OUT OF THE 8 SCREWS WITH LARGER SIZED SCREWS TO CORRECT THE SCREW TRACT. THERE WAS A SURGICAL DELAY OF 180 MINUTES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Spinal Column Injury

  MAUDE report 20100600 ↗
• InjuryJul 17, 2024Imprecision; Insufficient Device Problem Information; Imprecision; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT EXPERIENCED ARTERIAL BLEEDING DURING A NAVIGATED C1-C2 POSTERIOR FUSION CASE. THE SURGEON SUCCESSFULLY IMPLANTED NON-STRYKER SCREWS (DEPUY) ON THE LEFT SIDE. DURING PREPARATION FOR PLACEMENT OF THE RIGHT SIDE, NON-STRYKER C1 SCREW (DEPUY), THE SURGEON NOTED, " THE PATIENT STARTED TO BLEED." THE SPINOUS PROCESS CLAMP WAS REMOVED AND THE BLEEDING WAS STABILIZED. THE SURGEON THEN RE-REGISTERED THE PATIENT AND THE NAVIGATED DRILL GUIDE AND WAS SATISFIED WITH THE ACCURACY. THE SURGEON WAS ADVANCING THE DRILL A SECOND TIME AND THE PATIENT STARTED TO BLEED AGAIN. THE PROCEDURE WAS NOT COMPLETED AS PLANNED AND THE PATIENT RECEIVED A BLOOD TRANSFUSION. IT WAS REPORTED THAT AT THEIR 7 DAY POST OPERATIVE CHECK-UP, THE PATIENT WAS FINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19767370 ↗
• MalfunctionJul 17, 2024Imprecision; Imprecision

  IT WAS REPORTED THAT, DURING REGISTRATION OF THE SPINEMAP 3D SOFTWARE, THE SYSTEM WAS INACCURATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19761219 ↗
• MalfunctionApr 25, 2024Imprecision; Incorrect Measurement; Imprecision; Incorrect Measurement

  IT WAS REPORTED THAT WHEN USING THE SPINE MAP 3D 3.1 SOFTWARE, THE ACCURACY WAS OFF BY 2-3 MILLIMETERS WHICH MADE NAVIGATION AND SCREW PLACEMENT DIFFICULT FOR THE SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19187723 ↗
• MalfunctionApr 25, 2024Imprecision; Incorrect Measurement; Imprecision; Incorrect Measurement

  IT WAS REPORTED THAT WHEN USING THE SPINE MAP 3D 3.1 SOFTWARE, THE ACCURACY WAS OFF BY 2-3 MILLIMETERS WHICH MADE NAVIGATION AND SCREW PLACEMENT DIFFICULT FOR THE SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19187714 ↗
• MalfunctionAug 10, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, THE DEVICE DISPLAY WAS "BOUNCING" DURING A PROCEDURE AND SHOWED DEVIATIONS UP TO 5 MM. 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 17497239 ↗
• InjuryAug 3, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, THE SURGEON PLACED PEDICLE SCREWS IN A PATIENT WITH NAVIGATION. ONCE ALL SCREWS WERE PLACED, THE SURGEON REQUESTED ANOTHER SPIN TO CHECK SCREW POSITIONING. 4 OF THE 6 SCREWS WERE MALPOSITIONED, SO HE REMOVED ALL HARDWARE AND ABORTED THE CASE. THE PROCEDURE WAS RESCHEDULED FOR THE NEXT DAY AND COMPLETED SUCCESSFULLY, NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17451379 ↗
• MalfunctionAug 1, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, DURING THE AUTOMATIC REGISTRATION THE DEVICE WAS DEEMED INACCURATE. 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 17434331 ↗
• MalfunctionJul 25, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, THERE WERE INACCURACIES DURING THE CASE GREATER THAN 5MM. 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 17393853 ↗
• MalfunctionJun 7, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, WHILE PERFORMING MIS FUSION CASE THE NAV LOCKED GEAR SHIFT WAS INACCURATE. THE DEVICE SHOWED THAT THE INSTRUMENT WAS DIRECTLY DOWN THE PEDICLE, HOWEVER FLUORO SHOWED THE INSTRUMENT LATERAL WITH NO PART OF IT IN BONE. AFTER RECALIBRATING, THE INSTRUMENTS ACCURACY WAS BETTER BUT SOON LOST ACCURACY AFTER BEING PROGRESSED DOWN THE PEDICLE. WITHIN THE SAME SCREW HOLE, THE SURGEON WOULD ROTATE THE INSTRUMENT AND DEPENDING ON WHICH SIDE THE TRACKER WAS MOVED, IT WOULD SHOW THE INSTRUMENT IN TWO COMPLETELY DIFFERENT LOCATIONS (BOTH OF WHICH WERE INACCURATE). 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 17079234 ↗
• MalfunctionApr 5, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, DURING A L5/S1 FIXATION WITH NAVIGATION AFTER POSITIONING ALL 4 SCREWS WITH NAVIGATION AND HAVING TAKEN FINAL IMAGE ACQUISITION NOTICED ONE OF THE SCREWS (RIGHT L5) APPEARED TO BE MORE LATERAL THAN IT SHOWED WHEN PLACING THE SCREW WITH NAVIGATION. THE SCREW WAS REPOSITIONED WITH X-RAY. 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 16682536 ↗
• MalfunctionMar 22, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, DURING A POSTERIOR LUMBAR FUSION USING NAV3I AND ZIEHM, THE SURGEON COMPLAINED OF INACCURACY. AFTER CONDUCTING THE FIRST SPIN (0.33MM AUTOMATIC REGISTRATION DEVIATION) AND COMPLETING THE RIGHT SIDE WITH KWIRES THE SURGEON MOVED TO THE LEFT SIDE, AND COMPLAINED THAT "ACCURACY WAS OFF." THE CUSTOMER ATTRIBUTED THE NGENIUS TRACKER (ON ORTHOPINS) AS POTENTIALLY BEING "BUMPED." A SECOND SPIN (0.50MM DEVIATION) WAS CONDUCTED AND 6 SCREWS WERE PLACED IN THE PATIENT. THE SURGEON WAS STILL UNSURE OF ACCURACY, SO THREE STAPLES WERE PLACED IN THE PATIENTS BACK WITHIN THE SCAN CENTER AND A THIRD SPIN WAS CONDUCTED (0.43MM DEVIATION). AFTER CONDUCTING THE SPIN AND REMOVING THE Z-DRAPE, ACCURACY WAS CHECKED WITH THE LONG POINTER DOWN THE CENTER OF ONE OF THE SCREW TULIPS AND TOUCHING ON THE STAPLES, THERE STILL APPEARED TO BE INACCURACY. 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 16589495 ↗
• MalfunctionJan 3, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, THE SURGEON FELT THE THORACIC PROBE WAS INACCURATE DURING SURGERY. PER THE SURGEON, THE SOFT TISSUE DEFLECTS THE INSTRUMENT WHILE USING THE DEVICE WHEN NAVIGATING ON THE BONE, CAUSING TIP INACCURACIES. 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 16087475 ↗
• MalfunctionNov 23, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY DURING A MINIMALLY INVASIVE L4-S1 CASE AFTER THE DOCTOR BEGAN INSERTING THE K-WIRE AND FELT THAT THE PLACEMENT WAS NOT ACCURATE. THE CUSTOMER CONFIRMED THE K-WIRES WERE NOT POSITIONED IN THE BONE AND INSTEAD "RIDING THE NERVE ROUTE." THE DEVICE WAS RE-DIGITIZED AND THE SURGEON PLACED NEW K-WIRES TO COMPLETE THE CASE WITHOUT FURTHER ISSUES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15855101 ↗
• MalfunctionSep 24, 2022Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, THE ACCURACY OF THE NAVIGATION SYSTEM APPEARED TO BE OFF 2-3MM IN THE MEDIAL/LATERAL. TWO CALIBRATIONS WERE PERFORMED AND BOTH SHOWED THE SAME DEGREE OF INACCURACY FOR ALL TOOLS. THE SURGEON DECIDED TO USE THE DEVICE FOR THE REST OF THE CASE BUT STATED HE NEEDED TO UTILIZE ANATOMICAL LANDMARKS TO ENSURE HE WAS PLACING SCREWS CORRECTLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15478011 ↗
• MalfunctionSep 6, 2022Incorrect Measurement; No Device Output; Incorrect Measurement; No Device Output

  PER THE CUSTOMER, DURING THE REGISTRATION PROCESS USING THE IMAGE GUIDED SYSTEM THE REGISTRATION PROCESS FAILED DURING THE SURFACE REFINEMENT SECTION WHICH CAN LEAD TO INACCURACIES DURING THE 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 15362504 ↗
• MalfunctionAug 31, 2022Incorrect Measurement; No Device Output; Incorrect Measurement; No Device Output

  PER THE CUSTOMER THE DEVICE WAS INACCURATE DURING A PROCEDURE, THE DEVICE DISPLAYED AN ERROR STATING REGISTRATION HAD FAILED AND PATIENT ANATOMY LANDMARKS HAD BEEN COMPROMISED. 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 15328981 ↗
• MalfunctionAug 24, 2022Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, STARTING WITH THE DEVICE SHOWED INACCURACIES WHEN PLACING THE FOURTH SCREW DURING A SPINE 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 15285659 ↗
• MalfunctionAug 22, 2022Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER DURING A PROCEDURE THE DEVICE SHOWED INACCURATE POSITIONING OF NAVIGATED TRACKERS. THE DEVICE WAS NOT ABLE TO BE SUCCESSFULLY RECALIBRATED AND USE OF THE NAVIGATED DEVICE WAS ABORTED. 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 15264694 ↗
• MalfunctionAug 19, 2022Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, THE DEVICE WAS INACCURATE DURING A CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15259448 ↗
• MalfunctionJul 27, 2022Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER THERE WAS AN INACCURACY DURING AN IMAGE GUIDED SURGERY. 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 15113631 ↗
• MalfunctionJun 19, 2022Imprecision; Incorrect Measurement; Imprecision; Incorrect Measurement

  PER THE CUSTOMER, THERE IS A VARIANCE/INACCURACY BETWEEN THE SMART INSTRUMENTATION AND THE INSTRUMENTS THAT WERE CALIBRATED AND VALIDATED WITH A NAVLOCK. 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 14741322 ↗
• MalfunctionJun 7, 2022Imprecision; Incorrect Measurement; Imprecision; Incorrect Measurement

  IT WAS REPORTED BY THE CUSTOMER THAT DURING AUTO-REGISTRATION THE DEVICE PRODUCED DEVIATIONS FROM 1.5MM TO 5MM. USE OF THE DEVICE WAS ABORTED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICALLY-SIGNIFICANT DELAY USING X-RAYS FOR GUIDANCE. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14620957 ↗