NA 9734716Recalls & reported problems

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 00643169936294), received between Feb 8, 2017 and Oct 30, 2025 — classified as 5 injuries, 73 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (37 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 25 most recent of 78 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SPINOUS PROCESS CLAMP TALL AND THE SPINOUS PROCESS CLAMP SHORT WOULD NOT FULLY CLAMP ON TO THE SPINOUS PROCESS AND THE SURGEON HAD TO EXTEND THEIR ENTRY IN ORDER TO GET IT TO FULLY CLAMP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23426115 ↗
• MalfunctionOct 30, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SPINOUS PROCESS CLAMP TALL AND THE SPINOUS PROCESS CLAMP SHORT WOULD NOT FULLY CLAMP ON TO THE SPINOUS PROCESS AND THE SURGEON HAD TO EXTEND THEIR ENTRY IN ORDER TO GET IT TO FULLY CLAMP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23426108 ↗
• MalfunctionFeb 18, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SPINE CLAMP WAS DEFECTIVE. THE CLIP COULD NOT BE CLOSED. IT SEEMED THAT THE THREAD OF THE SCREW WAS WORN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21401027 ↗
• MalfunctionMar 5, 2020Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE CLAMP WOULD NOT LOCK. THE CLAMP HAD DIFFICULTY ENGAGING WHEN FULLY EXTENDED. IT WAS NOTED THAT THE SITE WAS EVENTUALLY ABLE TO GET THE CLAMP TO LOCK USING A 3RD PARTY TOOL. THERE WAS A 10 MINUTE SURGICAL DELAY AND NO IMPACT ON THE PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9794283 ↗
• MalfunctionFeb 10, 2020Material Integrity Problem; Material Integrity Problem

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT TO TROUBLESHOOT, THE SITE TRIED INSTRUMENT MILK (LUBRICANT) AND WORKING WI TH THE SCREW WITH NO SUCCESS. THERE ARE MULTIPLE SPINE CLAMPS IN THE TRAY AND THEY USED THE FUNCTIONAL CLAMP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9687987 ↗
• MalfunctionOct 22, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SURGEON COULD NOT ADJUST THE SCREW IN THE CLAMP TO OPEN AND IT WAS PREVENTING THE CLAMP FROM BEING USED. THE REPRESENTATIVE NOTED THE SCREW TOP LOOKED JAMMED. THE SITE USED A DIFFERENT CLAMP TO PROCEED WITH THE PROCEDURE. THERE WAS NO REPORTED DELAY AND NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9220850 ↗
• MalfunctionSep 5, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE DEVICE WAS FOUND IN A HOSPITAL BOX LABELED ¿DAMAGED¿ IN THE STERILE PROCESSING DEPARTMENT AT THE FACILITY. THE BOX CONTAINED SEVERAL USED INSTRUMENTS. THERE WAS NO FURTHER CONTEXT ABLE TO BE PROVIDED BY THE INITIAL REPORTER. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8965606 ↗
• MalfunctionJun 11, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THE SITE HAD DIFFICULTY TIGHTENING THE SHORT SPINOUS PROCESS CLAMP TO THE PATIENT, BECAUSE THE SCREW WOULD NOT TIGHTEN DOWN. A LONG CLAMP WAS USED INSTEAD. THIS ISSUE OCCURRED INTRAOPERATIVELY AND DID NOT CAUSE ANY SURGICAL DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8687314 ↗
• MalfunctionApr 30, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION INSTRUMENT OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE SITE HAD A DAMAGED SPINE CLAMP. NO PATIENT WAS PRESENT. FOLLOW-UP WITH THE MANUFACTURER REPRESENTATIVE (REP) DETERMINED THAT THE CLAMP WOULD NOT CLAMP ONTO THE ANATOMY.

  Patient problems: No Patient Involvement

  MAUDE report 8566133 ↗
• MalfunctionApr 30, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SPINE CLAMP WAS DAMAGED. THE WASHER SHEARED OFF.

  Patient problems: No Patient Involvement

  MAUDE report 8565344 ↗
• InjuryDec 9, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SITE WAS NOT ABLE TO GET THE SPINE CLAMP ONTO THE SPINOUS PROCESS. THE SURGEON TOOK A COBB AND SHAVED DOWN THE SIDE OF THE BONE A LITTLE TO GET THE CLAMP BACK ON AFTER BEING OPENED ALL THE WAY IN ORDER TO GET THE SCREW AND THREAD TO ENGAGE. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME AND THE PROCEDURE WAS COMPLETED USING NAVIGATION. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF THREE MINUTES DUE TO THIS ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8145358 ↗
• MalfunctionOct 23, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE OF A PROCEDURE, THE SPINE CLAMP WAS REPORTED TO BE DAMAGED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7995407 ↗
• MalfunctionOct 22, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE IN A SPINAL FUSION, THE SPINE CLAMP WOULD NOT TIGHTEN WHEN PLACED ON THE SPINOUS PROCESS. IT WAS REPORTED THAT A SECOND CLAMP WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7990156 ↗
• MalfunctionOct 17, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE A PROCEDURE. IT WAS REPORTED THAT THE SHORT SPINOUS PROCESS CLAMP WOULD NOT TIGHTEN PROPERLY, IT APPEARS "NIT" WAS THREADED. THE SITE USED THE LONG CLAMP FOR THEIR CASE INSTEAD. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 7975670 ↗
• MalfunctionSep 21, 2018Difficult to Open or Close; Difficult to Open or Close

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE. IT WAS REPORTED THAT THE SHORT SPINOUS CLAMP WAS BEING DIFFICULT TO PUT ON AND TAKE IT OFF. IT TAKES 10-15 MINUTES TO TAKE OFF OF THE SPINOUS PROCESS, ALMOST RESORTING TO TAKING OFF THE PROCESS. THE SITE HAD REPLACED THIS PART A COUPLE OF TIMES ALREADY.

  Patient problems: No Patient Involvement

  MAUDE report 7897320 ↗
• MalfunctionJul 3, 2018Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. THE ISSUE OCCURRED INTRAOPERATIVELY DURING EQUIPMENT SETUP AND CAUSED A FIVE-MINUTE DELAY TO THE SURGERY. IT WAS REPORTED THAT THE SURGEON HAD TROUBLE ENGAGING THE SCREW WITH THE SHORT SPINE CLAMP. HE STRUGGLED FOR ABOUT 5 MINUTES AND THEN WAS ABLE TO GET IT. THE SURGERY WAS COMPLETED WITH NAVIGATION AND THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7660340 ↗
• MalfunctionJun 27, 2018Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SPINE CLAMP WAS DAMAGED. THE RETENTION SCREW WAS STRIPPED. THERE WAS NO PATIENT IMPACT AND A LESS THAN 5 MINUTE DELAY WHILE A NEW TRAY WAS OPENED TO GET ANOTHER CLAMP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7643827 ↗
• MalfunctionMay 7, 2018Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE OF PROCEDURE, THE SCREW OF THE SPINE CLAMP WOULD NOT PROPERLY ENGAGE AND DOES NOT TIGHTEN. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 7490313 ↗
• MalfunctionApr 12, 2018Mechanical Problem; Mechanical Problem

  A SITE REPRESENTATIVE REPORTED THAT WHILE OUTSIDE OF PROCEDURE, THE SPINE CLAMP WAS HEAVY TO OPEN OR CLOSE. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 7426959 ↗
• MalfunctionApr 6, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A SITE REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE SPINE CLAMP COULD NOT BE OPENED TO BE PLACED ON THE SPINOUS PROCESS. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7402841 ↗
• MalfunctionApr 4, 2018Mechanical Problem; Mechanical Problem

  A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING SPINAL FUSION PROCEDURE, THE SHORT SPINE CLAMP WAS DAMAGED. IT WAS DIFFICULT TO REMOVE THE CLAMP FROM THE SPINE. THE PROCEDURE WAS COMPLETED WITH THE USE OF NAVIGATION. THERE WAS A DELAY OF LESS THAN 1 HOUR. NO KNOWN IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7397664 ↗
• MalfunctionApr 4, 2018Material Deformation; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE SPINE CLAMP COULD NOT BE OPENED WHEN PROMPTED BY THE USER. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7396035 ↗
• MalfunctionMar 26, 2018Mechanical Problem; Mechanical Problem

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE SPINE CLAMP COULD NOT BE TIGHTENED SUFFICIENTLY. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7370753 ↗
• MalfunctionMar 23, 2018Mechanical Problem; Mechanical Problem

  A SITE REPRESENTATIVE REPORTED THAT DURING SPINAL FUSION PROCEDURE, THE SPINE CLAMP WOULD NOT TIGHTEN ON THE SPINOUS PROCESS. SITE USED ANOTHER CLAMP TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE USE OF NAVIGATION. THERE WAS A DELAY OF ABOUT A MINUTE. NO KNOWN IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7367767 ↗
• MalfunctionMar 11, 2018Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINAL FUSION, THE SPINE CLAMP WAS FOUND TO HAVE A WASHER MISSING FOLLOWING ITS USE IN THE PROCEDURE. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7329898 ↗