NA 9734724Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169936461), received between Feb 9, 2017 and May 2, 2018 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 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.

• MalfunctionMay 2, 2018Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT DURING SPINAL FUSION PROCEDURE, THE SPINE CLAMP BROKE WHEN REMOVING FROM THE PATIENT. THERE WAS NO DELAY TO PROCEDURE. NO KNOWN IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7479171 ↗
• MalfunctionApr 25, 2018Break; Difficult to Open or Close; Break; Difficult to Open or Close

  INFORMATION WAS RECEIVED REGARDING AN INSTRUMENT THAT WAS USED DURING A SPINAL FUSION PROCEDURE. IT WAS REPORTED THAT DURING THE CASE, THE HEALTHCARE PROVIDER (HCP) WAS TRYING TO OPEN THE INSTRUMENT TO FIT IT ON THE SPINOUS PROCESS AND BACKED THE SCREW OUT TOO FAR. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7457614 ↗
• MalfunctionNov 20, 2017Mechanical Problem; Mechanical Problem

  A SITE REPRESENTATIVE REPORTED THAT DURING SPINAL FUSION CERVICAL PROCEDURE, CLAMP HAD A LOOSE SCREW. THE PROCEDURE WAS COMPLETED WITH THE USE OF NAVIGATION. THERE WAS NO DELAY TO PROCEDURE. NO INFORMATION WAS PROVIDED ON PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7046436 ↗
• MalfunctionNov 15, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A PROCEDURE, THE SPINE CLAMP WAS FOUND TO BE DAMAGED. THE REPRESENTATIVE REPORTED THAT THE PATIENT WAS AFFECTED, HOWEVER NO ADDITIONAL DETAILS WERE PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7034525 ↗
• MalfunctionOct 3, 2017Material Deformation; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A SPINAL FUSION PROCEDURE THE WASHER OF THE DOUBLE SPINE CLAMP WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH THE USE OF NAVIGATION. THERE WAS A DELAY OF LESS THAN 1 HOUR. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6909475 ↗
• MalfunctionMay 5, 2017Material Deformation; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINE PROCEDURE, THE SITE'S DOUBLE PROCESS SHORT CLAMP HAD A BROKEN WASHER. SURGEON WAS ATTEMPTING TO PLACE THE CLAMP ON THE PATIENT WHEN THE WASHER BROKE. SURGEON REMOVED THE BROKEN WASHER FROM THE PATIENT AND USED A SECOND DOUBLE PROCESS SHORT CLAMP FROM ANOTHER TRAY TO CONTINUE THE PROCEDURE. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW 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 REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6549307 ↗
• MalfunctionApr 28, 2017Material Deformation; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINAL FUSION PROCEDURE, THE SITE HAD A DAMAGED SPINOUS PROCESS CLAMP. THE WASHER CAME OFF WHEN TRYING TO REMOVE THE CLAMP. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED. THE SURGEON OPTED TO CONTINUE AND COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. DELAY IN THERAPY WAS 15 MINUTES. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6529561 ↗
• MalfunctionMar 31, 2017Break; Mechanical Problem; Break; Mechanical Problem

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINAL FUSION, THE SPINE CLAMP BECAME DAMAGED WHEN REMOVING IT FROM THE SPINOUS PROCESS. THE SUSPECT CLAMP DID NOT COME INTO CONTACT WITH THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6450657 ↗
• MalfunctionFeb 9, 2017Material Deformation; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINE PROCEDURE, THE SURGEON WAS USING THE SPINOUS PROCESS CLAMP AND DID NOT STOP WHEN THE CLAMP WAS OPEN. THIS CAUSED CLAMP SCREWS TO BECAME DAMAGED. A SECOND CLAMP WAS BROUGHT IN TO BE USED TO CONTINUE THE PROCEDURE TO COMPLETION. DELAY IN THERAPY WAS LESS THAN 10 MINUTES. THERE WAS NO IMPACT ON PATIENT OUTCOME. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S SPINOUS PROCESS SHORT CLAMP. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6315612 ↗