N/A 9732520Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994123565), received between Nov 29, 2016 and Jun 24, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 16, 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.

• MalfunctionJun 24, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM WHILE OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE SITE COULD NOT LOCK THE PINS ON THE QUICK RELEASE BASE. THERE WAS NO PATIENT PRESENT WHEN THE ISSUE OCCURRED.

  Patient problems: No Patient Involvement

  MAUDE report 8729024 ↗
• MalfunctionMay 4, 2017Device Inoperable; Material Deformation; Device Inoperable; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINE PROCEDURE, THE SITE STATED THAT THE PIN COULD NOT BE REMOVED FROM THEIR QUICK RELEASE BASE. NO FURTHER DETAILS REGARDING THIS ISSUE, OR SPECIFICALLY WHEN IT OCCURRED, WERE PROVIDED. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO DELAY OF THERAPY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6546581 ↗
• MalfunctionNov 29, 2016Mechanical Problem; Material Deformation; Unintended Movement; Mechanical Problem; Material Deformation; Unintended Movement

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, DURING PREPARATION FOR A SPINE PROCEDURE, THE SURGEON ALLEGED AN ISSUE WITH THEIR QUICK RELEASE BASE. REPORTED WAS THAT A FIXATION PIN WAS PUT THROUGH THE QUICK RELEASE BASE. WHILE AN ATTEMPT WAS MADE TO IMPLANT A DRILL(S), GAUZE WAS INTERFERING. A BACK-UP PRODUCT WAS USED TO CONTINUE THE PROCEDURE INSTEAD. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO DELAY OF THERAPY REPORTED. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6134085 ↗