N/A 9733148Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00613994201263), received between Feb 20, 2017 and Oct 29, 2024 — classified as 1 injury, 35 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (22 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 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM OUTSIDE OF PROCEDURE. IT WAS REPORTED THERE WERE NO SCREWS TO STOP THE CLAMP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20559322 ↗
• MalfunctionApr 17, 2020Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE SPINE CLAMP WAS DAMAGED. THE CLAMP COULD NOT OPEN AND CLOSE CORRECTLY. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Patient Involvement

  MAUDE report 9973841 ↗
• MalfunctionNov 18, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE SITE HAD MULTIPLE DAMAGED INSTRUMENTS. THE CLAMP WAS STUCK ON THE TRACKER. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9335089 ↗
• MalfunctionOct 8, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE A PROCEDURE. IT WAS REPORTED THAT THE SCREW ON THE RADIOLUCENT SPINE CLAMP WAS STRIPED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 9166176 ↗
• MalfunctionAug 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 DISCOVERED TWO DAMAGED SPINOUS PROCESS CLAMPS. THE SHORT SINGLE CLAMP WAS MISSING A SCREW. THE LONG SINGLE CLAMP DOES NOT PROPERLY GRIP. IT MOVES AFTER THE FASTENING SCREW HAS BEEN TIGHTENED. THERE WAS LESS THAN AN HOUR DELAY TO THE PROCEDURE. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8921098 ↗
• MalfunctionJun 28, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE. IT WAS REPORTED THE THORACIC RADIOLUCENT SPINE CLAMP HAD PROBLEMS IN OPENING AND CLOSING. THIS ISSUE WAS NOTED OUTSIDE OF A PROCEDURE, AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8746147 ↗
• MalfunctionJun 6, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION INSTRUMENT OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE SPINE CLAMP WAS STRIPPED. NO PATIENT WAS PRESENT.

  Patient problems: No Patient Involvement

  MAUDE report 8674755 ↗
• MalfunctionMar 30, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SITE HAD A BROKEN INSTRUMENT THAT NEEDED REPLACEMENT. THE THORACIC CLAMP'S SCREW THREAD WAS DEFRAGMENTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8467958 ↗
• MalfunctionFeb 6, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE. IT WAS REPORTED THAT THE SCREW OF A SPINE CLAMP WAS WORN. THIS WAS OBSERVED OUTSIDE OF A SURGICAL PROCEDURE. NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 8310648 ↗
• MalfunctionNov 19, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE CLAMP¿S TIGHTENING SCREW HEAD HAD STARTED TO WEAR SIGNIFICANTLY AND HAD LOST PURCHASE FOR STRONG TIGHTENING. THE CLAMP JAWS HAD ALSO BECOME MISALIGNED AND TIGHTENED INTO AN INCORRECT POSITION. THE STERILE CLAMP WAS ASSESSED BEFORE THE PATIENT WAS BROUGHT INTO THE OPERATING ROOM, AND IT WAS DECIDED THAT THEY WOULD USE THE LONG LUMBAR CLAMP AS AN ALTERNATIVE REPLACEMENT FOR THE CASE. THE CLAMP WAS STILL USABLE FOR THE CASE, BUT IT WAS NO LONGER RELIABLE AND REQUIRED REPLACING. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS OBSERVED.

  Patient problems: No Patient Involvement

  MAUDE report 8083929 ↗
• MalfunctionOct 10, 2018Material 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 SITE HAD A STRIPPED SCREW ON THEIR SPINOUS PROCESS CLAMP. THIS ISSUE WAS NOTICED INTRA/PERI-OPERATIVELY DURING THE SELECT PATIENT/ACQUIRE SCANS TASK. THE SITE SAID THE DRIVER FOR THE CLAMP HAD BECOME ROUNDED AND MAY HAVE CONTRIBUTED TO THE ISSUE. THE SURGEON WAS ABLE TO TIGHTEN THE CLAMP SUFFICIENTLY FOR THE CASE. THERE WAS NO DELAY TO THE PROCEDURE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7954614 ↗
• MalfunctionOct 9, 2018Material 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 REQUIRED REPLACEMENT. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS OBSERVED.

  Patient problems: No Patient Involvement

  MAUDE report 7948649 ↗
• MalfunctionFeb 19, 2018Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF PROCEDURE, WITH NO PATIENT PRESENT. IT WAS REPORTED THAT THE SCREW OF THE REFERENCE CLAMP WAS WORN AND NEEDED A REPLACEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7280890 ↗
• MalfunctionFeb 9, 2018Mechanical Problem; Device Operates Differently Than Expected; Mechanical Problem; Device Operates Differently Than Expected

  A SITE REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE ADJUSTMENT SCREW HEAD WAS WORN ON THE CLAMP. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7259929 ↗
• MalfunctionJan 16, 2018Material Deformation; Material Deformation

  A SITE REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, AN INSTRUMENT WAS DAMAGED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7197789 ↗
• MalfunctionJan 11, 2018Material Deformation; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE OUTSIDE OF A PROCEDURE, WHEN PERFORMING AN INSTRUMENT INSPECTION IN STERILE PROCESSING, THE THORACIC CLAMP WAS OBSERVED TO BE DAMAGED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 7182753 ↗
• MalfunctionJan 11, 2018Material Deformation; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE SCREW HEAD OF THE ADJUSTMENT SCREW FOR THE SPINE CLAMP WAS STRIPPED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7182566 ↗
• MalfunctionDec 18, 2017Material Deformation; Material Deformation

  A SITE REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE SPINE CLAMP WAS STRIPPED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7126150 ↗
• MalfunctionDec 18, 2017Material Deformation; Material Deformation

  A SITE REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE SPINE CLAMP AS STRIPPED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7125994 ↗
• MalfunctionDec 18, 2017Material Deformation; Material Deformation

  A SITE REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE SPINE CLAMP WAS STRIPPED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7125970 ↗
• MalfunctionDec 18, 2017Material Deformation; Material Deformation

  A SITE REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE SPINE CLAMP WAS STRIPPED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7125872 ↗
• MalfunctionDec 7, 2017Material Deformation; Material Deformation

  A SITE REPRESENTATIVE REPORTED THAT WHILE OUTSIDE OF SURGERY, THE SCREW OF THE SPINE CLAMP WAS STRIPPED. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 7095129 ↗
• MalfunctionDec 6, 2017Material Deformation; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE OUTSIDE OF PROCEDURE, A SCREW OF THE SPINOUS PROCESS CLAMP HAS STRIPPED. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 7087495 ↗
• MalfunctionOct 26, 2017Material Deformation; Material Deformation

  A SITE REPRESENTATIVE REPORTED THAT WHILE OUTSIDE OF PROCEDURE, THE SCREW OF THORACIC CLAMP WAS STRIPPED. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 6980194 ↗
• MalfunctionOct 25, 2017Material Deformation; Material Deformation

  A SITE REPRESENTATIVE REPORTED THAT WHILE OUTSIDE OF SURGERY, A SCREW OF THE SPINE CLAMP WAS STRIPPED. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 6977635 ↗