NA 9734715Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 00643169936300), received between Feb 14, 2017 and Mar 4, 2025 — classified as 2 injuries, 59 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (26 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 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE CLAMP WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE SUSPECTED CAUSE OF THE ISSUE WAS EXTENDED USE OF THE CLAMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21516104 ↗
• MalfunctionOct 6, 2020Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE LONG SPINOUS PROCESS CLAMP WAS DAMAGED, AS THE SCREW AND THE WASHERS BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10636881 ↗
• MalfunctionNov 13, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE WASHER ON THE CLAMP FELL ONTO THE FLOOR AND THEREFORE THE CLAMP WOULD NOT CLOSE. THE SITE SWITCHED TO THE SHORT CLAMP AND CONTINUED WITHOUT ANY ISSUES. THERE WAS LESS THAN AN HOUR DELAY IN THE CASE. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9314563 ↗
• MalfunctionJul 29, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS A DAMAGED SPINE CLAMP FOUND PRIOR TO CASES. THE CLAMP IS FREE-MOVING WHETHER THE SCREW IS ENGAGED OR DISENGAGED.

  Patient problems: No Patient Involvement

  MAUDE report 8837263 ↗
• MalfunctionJul 23, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT A SPINE CLAMP WILL NOT OPEN. THIS WAS FOUND IN PREPARATION FOR A CASE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8818036 ↗
• MalfunctionJun 26, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE OF A PROCEDURE, THE SPINE CLAMP WAS DIFFICULT TO PLACE ON MEDIUM TO LARGE SPINOUS PROCESSES. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8737627 ↗
• MalfunctionJun 20, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE SPINE CLAMP WILL NOT OPEN OR CLOSE. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8718181 ↗
• MalfunctionMay 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE CLAMP CAN'T BE FIXED. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8643251 ↗
• MalfunctionApr 19, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE OF A PROCEDURE, THE SPINOUS PROCESS CLAMP WOULD NOT OPEN WHEN THE CLAMP WAS UNSCREWED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8531222 ↗
• MalfunctionMar 26, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR SACROILIAC AND THORACOLUMBAR. IT WAS REPORTED THAT DURING EQUIPMENT SETUP, THE CLAMP TALL HAD FAILED IN THE WASHER AT THE SCREW TIP THAT KEPT IT FROM BECOMING LOSE HAD COME OFF. ISSUE WAS NOTICED AT THE NEXT SURGERY IT WAS USED AT. THE WASHER WAS NOWHERE TO BE FOUND. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8451951 ↗
• MalfunctionJan 30, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT WHEN THE TEETH OF THE CLAMP ARE FULLY OPENED, THE CLOSING SCREW WAS NOT CATCHING THE TEETH SO THE SITE NEEDS TO HOLD THE TEETH BETWEEN THEIR FINGERS IN ORDER TO START TURNING THE SCREW TO CATCH AND CLOSE THE CLAMP TEETH, THE SITE EVALUATED ANOTHER CLAMP AND IT WAS WORKING DIFFERENTLY. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8290024 ↗
• MalfunctionJan 16, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION THAT THERE WAS NO PATIENT IMPACT DUE TO THE REPORTED ISSUE AND THERE WAS NO REPORTED DELAY DUE TO THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8252977 ↗
• MalfunctionJan 1, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE WASHER FELL OUT AND THE CLAMP WILL NO LONGER OPEN OR CLOSE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE OCCURRED.

  Patient problems: No Patient Involvement

  MAUDE report 8207407 ↗
• MalfunctionDec 18, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE A PROCEDURE. IT WAS REPORTED THAT THE TALL SPINOUS CLAMP WAS NOT WORKING ANYMORE. IT WAS NOT POSSIBLE TO TIGHTEN THE CLAMP.

  Patient problems: No Patient Involvement

  MAUDE report 8177331 ↗
• MalfunctionNov 26, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED INTRA/PERI-OPERATIVELY A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SPINE CLAMP WAS WAS BROKEN. THE SURGEON TRIED TO TAKE THE SPINE CLAMP OUT AND IT GOT STUCK. THE SURGEON MANAGED TO GET IT OUT AND ENDED UP REPLACING IT WITH ANOTHER SPINE CLAMP AND PROCEEDED WITH THE CASE. THERE WAS A LESS THAN 1-HOUR DELAY TO THE PROCEDURE AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8102743 ↗
• MalfunctionNov 6, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE TALL SPINE CLAMP WAS LOOSE, SO THE SITE CHANGED IT WITH A NEW ONE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8044628 ↗
• MalfunctionSep 21, 2018Difficult to Open or Close; Difficult to Open or Close

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE. IT WAS REPORTED THAT THE TALL PROCESS SPINOUS CLAMP HAS BEEN 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 7897289 ↗
• MalfunctionSep 20, 2018Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM EVENT HAVING OCCURRED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE SITE HAD A BROKEN TALL, ¿NEW STYLE¿ SPINE CLAMP. IT WAS STATED IT HAD A STRIPPED SCREW. NO PATIENT PRESENT.

  Patient problems: No Patient Involvement

  MAUDE report 7894734 ↗
• InjuryJul 5, 2018Break; Break

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A SACROILIAC AND THORACOLUMBAR. IT WAS REPORTED THAT THE TALL SPINE CLAMP WAS DAMAGED WHILE TRYING TO REMOVE IT. THE WASHER BROKE OFF THE CLAMP. THE SPINOUS PROCESS WAS FRACTURE WHEN TRYING TO REMOVE THE CLAMP.

  Patient problems: Spinal Column Injury; Tissue Damage

  MAUDE report 7665004 ↗
• MalfunctionJul 3, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT DURING A PROCEDURE THE LONG SPINE CLAMP WAS NOT HOLDING ADEQUATELY. IT WAS NOTED THAT THIS CLAMP WAS FROM ONE OF THEIR OLDER TRAYS, AROUND 5-6 YEARS OLD. THERE WAS NO REPORTED IMPACT TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7661048 ↗
• MalfunctionMay 23, 2018Fracture; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE. IT WAS REPORTED THAT THERE WAS A DAMAGED SPINE CLAMP. THE CLAMP WASHER IN ONE OF THE SPINE SETS HAD BROKEN OFF. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 7538724 ↗
• MalfunctionMay 7, 2018Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE OF PROCEDURE, THE THREAD OF THE FIXATION SCREW WAS WORN. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 7490164 ↗
• MalfunctionMay 1, 2018Break; Break

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE INSTRUMENT BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS A DAMAGED SPINE CLAMP. IT WOULD NOT CLOSE AND THE SCREW WOULD SPIN, BUT NOT ENGAGE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7476517 ↗
• MalfunctionApr 19, 2018Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT WHILE OUTSIDE OF PROCEDURE, THE SPINOUS CLAMP WAS NOT TIGHTENING PROPERLY TO THE SPINOUS PROCESS. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 7444338 ↗
• MalfunctionApr 5, 2018Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTH CARE REPRESENTATIVE VIA MANUFACTURE REPRESENTATIVE ABOUT A SPINE CLAMP FROM A NAVIGATION SYSTEM USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT DURING THE FUSION, IT WAS NOT POSSIBLE FOR THE CLAMP TO ENGAGE TO TIGHTEN IT AROUND THE SPINOUS PROCESS. A DIFFERENT CLAMP WAS SELECTED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE AND NO IMPACT ON THE PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7401279 ↗