N/A 9730605Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00721902812743), received between Feb 24, 2017 and Feb 21, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED INTRA-OPERATIVELY DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT ONE SPOT WAS NOT RECOGNIZED AND THAT AN INACCURACY OF 2-3 MILLIMETERS (MM) OCCURRED. NO KNOWN IMPACT TO PATIENT OUTCOME. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18748987 ↗
• MalfunctionDec 28, 2021Imprecision; Imprecision

  DURING THE PROCEDURE, THERE WAS AN ALLEGED INACCURACY OF APPROXIMATELY 2MM DUE TO INSTRUMENT DEFORMATION DURING NAVIGATION. THE PROCEDURE WAS COMPLETED BY THE USE OF BACKUP PRODUCTS. THE INACCURACY WAS ISOLATED TO THE PROBLEM INSTRUMENTS. THE REPORTED ISSUE DID NOT RESULT IN A PROCEDURE DELAY. THERE WAS NO IMPACT ON PATIENT OUTCOME. THE LIKELY CAUSE WAS REPORTED AS INSTRUMENT DETERIORATION OVER TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13102251 ↗
• MalfunctionSep 2, 2021Device Sensing Problem; Device Sensing Problem

  ADDITIONAL INFORMATION REGARDING A NAVIGATION SYSTEM. TROUBLESHOOTING WAS PERFORMED BUT WAS UNSUCCESSFUL TO RESOLVE THE ISSUE. THE SYSTEM WAS RESTARTED, CAMERA REPOSITIONED AND THE SITE WIPED DOWN THE SPHERES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12413627 ↗
• MalfunctionMar 22, 2021Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED OUTSIDE OF A PROCEDURE FOR SERVICING. IT WAS REPORTED THAT THE REFERENCE FRAME WAS NOT RECOGNIZED. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11544106 ↗
• MalfunctionSep 18, 2020Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM THAT WAS USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE ENGAGEMENT OF OPEN SPINE CLAMP AND REFERENCE FRAME WAS POOR. IT WAS ALSO STATED THE "SPINE CLAMP AND FRAME COULD NOT BE FASTEN SMOOTHLY." THE OPEN SPINE CLAMP WAS NOT ATTACHED TO THE REFERENCE FRAME WELL. THE PROCEDURE WAS COMPLETED WITH THE CONTINUOUS USE OF THE NAVIGATION SYSTEM. THERE WAS A REPORTED DELAY OF LESS THAN ONE HOUR. THERE IS NO KNOWN IMPACT ON PATIENT OUTCOME. IT WAS REPORTED THAT "ENGAGEMENT OF OPEN SPINE CLAMP AND REFERENCE FRAME WAS POOR" MEANS ¿THE OPEN SPINE CLAMP WAS NOT ATTACHED TO THE REFERENCE FRAME WELL¿

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10556684 ↗
• MalfunctionJun 29, 2020Device Sensing Problem; Device Sensing Problem

  2020-6-15 (B)(4) (REP FOR):MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE FRAME WAS NOT VISIBLE. IF THE FRAME WAS VISIBLE THEN THE INSTRUMENT WOULD VERIFY BUT WOULD BE INACCURATE OR UP TO 5MM. OTHER SMALL PASSIVE FRAMES WERE WORKING AS INTENDED. THERE WAS NOTED TO BE SOMETHING BENT ON THE FRAME.

  Patient problems: No Patient Involvement

  MAUDE report 10206834 ↗
• MalfunctionNov 29, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SPINE REFERENCE HAD A DEFECT AND WAS UNUSABLE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS OBSERVED.

  Patient problems: No Patient Involvement

  MAUDE report 8117522 ↗
• MalfunctionNov 27, 2018Degraded; Degraded

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT A SPINE REFERENCE FRAME WAS BROKEN DURING SURGERY. THE FRAME ADAPTER WAS HELD IN PLACE FOR THE REMAINDER OF THE PROCEDURE WHICH STERI-STRIPS. THERE WAS NO IMPACT TO PATIENT. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8108572 ↗
• MalfunctionFeb 24, 2017Material Deformation; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINE FUSION PROCEDURE, THE REFERENCE FRAME SCREWS, HOLDING THE FRAME TO THE ATTACHMENT MECHANISM, WERE STRIPPED CAUSING THE FRAME TO BE LOOSE. THIS WAS REPORTED TO OCCURRED WHILE PLACING THE FRAME ONTO THE CLAMP. A SECOND DEVICE WAS BROUGHT IN TO BE USED IN CONTINUING THE PROCEDURE, NO FURTHER DETAILS REGARDING THIS ISSUE, OR SPECIFICALLY WHEN IT OCCURRED, WERE PROVIDED. THE SURGEON OPTED TO CONTINUE AND COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. DELAY IN THERAPY WAS 10 MINUTES. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6356909 ↗