N/A 9732353 (UDI 00763000340179)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000340179), received between Sep 2, 2021 and Mar 10, 2026 — classified as 3 malfunctions.

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

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Activation, Positioning or Separation Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT WHEN THE FRAME WAS PLACED ON THE PERCUTANEOUS PIN AND IMAGE WAS TAKEN, THE FRAME ROTATED AWAY BECAUSE THE NOTCH HAD BROKEN OFF. IT WAS UNKNOWN WHEN THE FRAME BROKE. IT WAS REPORTED THAT THE FRAME MOVED SINCE THE PERC PIN WAS NOT HOLDING THE FRAME IN PLACE. THE MOVEMENT CAUSED AN INACCURACY OF APPROXIMATELY 50MM. THE PROCEDURE WAS COMPLETED BY OPENING A NEW TRAY, PLACING A NEW STERILE REFERENCE FRAME ON THE PERC PIN AND COMPLETING A NEW IMAGING SYSTEM SPIN. THERE WAS A SURGICAL DELAY OF LESS THAN 1 HOUR. THERE WAS NO IMPACT ON PATIENT OUTCOME. 2026-FEB-26 E1 (REP): ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE FRAME MOVED SINCE THE PERC PIN WAS NOT HOLDING THE FRAME IN PLACE. THE MOVEMENT CAUSED AN INACCURACY OF APPROXIMATELY 50MM. THE PROCEDURE WAS COMPLETED BY OPENING A NEW TRAY, PLACING A NEW STERILE REFERENCE FRAME ON THE PERC PIN AND COMPLETING A NEW IMAGING SYSTEM SPIN. 2026-MAR-06 E2 (REP): NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559064 ↗
• MalfunctionFeb 10, 2026Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE PERCUTANEOUS (PERC) PIN REFERENCE FRAME WAS OBSERVED TO HAVE DAMAGE TO THE LOCKING MECHANISM, PREVENTING IT FROM LOCKING EFFECTIVELY TO THE PERC PIN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24307504 ↗
• 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 12413619 ↗