N/A 9732353 (UDI 00613994151179)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00613994151179), received between Dec 20, 2016 and Sep 6, 2024 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (10 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 6, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED INTRA-OPERATIVELY DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT DURING NAVIGATION, CHANGES WERE REPORTED BY THE NEUROLOGY MONITORING TECHNICIAN, A PROTOCOL WAS ACTIVATED AND THE DECISION WAS MADE TO SWITCH TO FLUOROSCOPIC IMAGES. AN INACCURACY OCCURRED DURING NAVIGATION. THE PERCUTANEOUS PIN WAS AIMING TO THE FEET.  MANUFACTURER IMAGING WAS ABORTED AND THE SITE COMPLETED THE PROCEDURE USING A NON-MANUFACTURER IMAGING SYSTEM.  CONFLICTING INFORMATION WAS RECEIVED REGARDING WHETHER OR NOT MANUFACTURER NAVIGATION WAS ABORTED OR NOT. AN EXPLORATION OF THE ANATOMY WAS PERFORMED. THERE WAS A ONE HOUR OR LONGER SURGICAL DELAY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20155920 ↗
• MalfunctionApr 18, 2024Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED INTRA-OPERATIVELY DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SMALL SPINE FRAME WAS FOUND TO BE LOOSE AFTER NAVIGATING PROBE AND NOTICING INACCURATE ANATOMY. A NEW TRAY WAS OPENED, A DIFFERENT FRAME WAS ATTACHED TO PERCUTANEOUS PIN, AND THE TEAM TOOK A NEW SPIN WITH NO FURTHER ACCURACY OR FRAME COMPLICATIONS. THE FIELD REPRESENTATIVE (REP) REPORTED THE SPRING ON THE FRAME SEEMED LOOSE, AS WELL AS TEETH VERY WORN DOWN, ALLOWING FRAME TO ROTATE EASILY AND MOVE BACK AND FORTH WITH LITTLE FORCE. PATIENT PRESENT. 5 MIN DELAY. NO KNOWN IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19133376 ↗
• MalfunctionJun 13, 2022Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE SITE NAVIGATED WITH THE NEEDLE AND REGISTERED ON TOP DIVOT WITHOUT ISSUE, THEN WAS 5-6MM INACCURATE CAUDALLY, EVEN THOUGH THE DOCTOR WAS DOCKED ON BONE. THEY RE-REGISTERED THE NEEDLE ON THE FRONT DIVOT OF THE FRAME AND IT WAS THEN ACCURATE. NO OTHER INSTRUMENTS HAS INACCURACY. THERE WAS NO REPORTED DELAY TO THE PROCEDURE. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14676369 ↗
• MalfunctionMay 20, 2022Imprecision; Mechanics Altered; Imprecision; Mechanics Altered

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS A 5-10MM INACCURACY DURING NAVIGATION. AUTO-REGISTRATION WAS USED. THE BALL TIP PLANA PROBE WAS BEING USED WHEN THE INACCURACY WAS DETECTED. ADDITIONALLY, A UNIVERSAL DRILL GUIDE (UDG) AND AWL TIP TAPS WERE BEING USED. THE PERCUTANEOUS PIN FRAME WAS BEING USED. THE FRAME WAS LOCATED AT THE RIGHT POSTERIOR SUPERIOR ILIAC SPINE (PSIS). THE PERCUTANEOUS PIN FRAME WAS LOOSE AND WOULD NOT TIGHTEN PROPERLY. AFTER IMAGES WERE TAKEN, THE IMAGES DID NOT MATCH ANY INSTRUMENTS. AFTER THE INACCURACY WAS DISCOVERED, A MIDLINE INCISION WAS MADE AND A SPINOUS PROCESS CLAMP WAS PLACED ON THE L4 SPINOUS PROCESS. ANOTHER IMAGE WAS TAKEN AND THE PROCEDURE WAS COMPLETED. THE PROCEDURE WAS DELAYED BY LESS THAN ONE HOUR. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14455141 ↗
• MalfunctionFeb 17, 2020Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE TEETH ON THEIR PERC PIN REFERENCE FRAME SEEM WORN FROM USE AND DON'T SIT AS SECURELY IN THE GROOVES AS THEY LIKE. THERE WAS A DELAY OF LESS THAN 1 HOUR. NO PATIENT IMPACT WAS CORRELATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9716665 ↗
• MalfunctionOct 11, 2019Material Integrity Problem; Material Integrity Problem

  ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THE EVENT. THE CONCERN WAS WITH A REFERENCE FRAME POST TEETH BEING BENT. THE SITE HAS CONTINUED TO USE THE REFERENCE FRAME POST FOR SEVERAL MORE CASES.

  Patient problems: No Patient Involvement

  MAUDE report 9180346 ↗
• MalfunctionOct 11, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THE BLUE PERC PIN REFERENCE FRAME WAS NOT STAYING IN PLACE. THE SPRING WAS BROKEN. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 9179480 ↗
• MalfunctionMar 8, 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 PERCUTANEOUS PIN WOULD NOT FIT INTO THE PERCUTANEOUS REFERENCE FRAME. THE END USER TRIED STERILE MINERAL OIL TO LUBRICATE THE POST BUT HAD NO SUCCESS. A SECOND PERCUTANEOUS PIN WAS TRIED WITHOUT SUCCESS. THE PIN WAS WEDGED INTO THE POST OF THE PERCUTANEOUS FRAME; NO MOVEMENT OF PIN TO FRAME WAS SEEN AND THE SURGEON MOVED FORWARD WITH THE PROCEDURE. NAVIGATION WAS NOT DISCONTINUED, AND MEDTRONIC IMAGING WAS USED AND COMPLETED WITHOUT INCIDENT. THERE WAS A SURGICAL DELAY OF LESS THAN 1 HOUR DUE TO THIS ISSUE, AND THERE WAS NO IMPACT ON PATIENT OUTCOME. IT WAS SUSPECTED THERE WAS DAMAGE TO THE REFERENCE FRAME WHEN TWO PERCUTANEOUS PINS OF DIFFERENT LOTS WOULD NOT FIT. THE SITE ORDERED AND RECEIVED A NEW FRAME AT A LATER DATE. AT THIS TIME A MEDTRONIC REPRESENTATIVE (REP) TRIED THE PERCUTANEOUS PINS SAVED FROM THE INCIDENT. THE SAME ISSUE OCCURRED WITH BOTH PERCUTANEOUS PINS. UPON ADVICE FROM TECHNICAL SERVICES (TS), A NEW PERCUTANEOUS PIN WAS OPENED FROM THE SHELF AND IT WOULD SUCCESSFULLY FIT INTO THE NEW FRAME BUT NOT THE OLD FRAME. IT WAS NO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8406316 ↗
• MalfunctionDec 26, 2018Imprecision; Material Integrity Problem; Imprecision; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SMALL PERC PIN TRACKER REFERENCE FRAME ¿JUMPED¿ AFTER A SPIN. THE REFERENCE FRAME WAS NOT BUMPED AND THE TEETH WERE FULLY SEATED UPON THE START OF THE SPIN. THE SITE DID AN ADDITIONAL SPIN. AFTERWARDS, IT WAS FOUND THAT THE TEETH WERE VERY WORN AND EASILY MOVABLE. THE SITE WAS TAKEN OUT OF CIRCULATION. THERE WAS NO PATIENT IMPACT REPORTED AND A LESS THAN ONE HOUR DELAY TO SURGERY.

  Patient problems: No Patient Involvement

  MAUDE report 8195118 ↗
• MalfunctionMar 12, 2018Mechanical Problem; Mechanical Problem

  A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE OUTSIDE OF PROCEDURE, THE PERC PIN REFERENCE FRAME WAS LOOSE. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 7330412 ↗
• MalfunctionFeb 9, 2018Mechanical Problem; Device Operates Differently Than Expected; Material Integrity Problem; Mechanical Problem; Device Operates Differently Than Expected; Material Integrity Problem

  A SITE REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, A SPRING ON THE REFERENCE FRAME WAS LOOSE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7261583 ↗
• MalfunctionNov 3, 2017Device Operates Differently Than Expected; Material Deformation; Device Operates Differently Than Expected; Material Deformation

  A SITE REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE PERC-PIN LOCKING MECHANISM WAS NOT FUNCTIONING. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7000226 ↗
• MalfunctionAug 11, 2017Mechanical Problem; Device Operates Differently Than Expected; Mechanical Problem; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINAL FUSION, THE PERC PIN WAS LOOSE RESULTING IN SLIGHT MOVEMENT OF THE REFERENCE FRAME. THE SITE ELECTED TO CONTINUE WITH THE FRAME AND ENSURING THAT THE FRAME WOULD NOT MOVE. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR 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 6788797 ↗
• MalfunctionAug 7, 2017Mechanical Problem; Mechanical Problem

  A SITE REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE REFERENCE FRAME WOULD NOT TIGHTEN. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6772298 ↗
• MalfunctionAug 4, 2017Mechanical Problem; Device Operates Differently Than Expected; Mechanical Problem; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE PER REFERENCE FRAME PIN WAS HANDLE/STEM WAS REPORTED TO HAVE BEEN DAMAGED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6768288 ↗
• MalfunctionJul 10, 2017Mechanical Problem; Mechanical Problem

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE CROSS PIN ON THE REFERENCE FRAME WAS NOT LOCKING SECURELY. THE REPORTED ISSUE WAS FOUND TO HAVE OCCURRED IN THE SITE'S STERILE PROCESSING DEPARTMENT (SPD). THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6698202 ↗
• MalfunctionJun 27, 2017Imprecision; Mechanical Problem; Device Operates Differently Than Expected; Imprecision; Mechanical Problem; Device Operates Differently Than Expected

  A SITE REPRESENTATIVE REPORTED THAT, WHILE IN A, WHILE IN A SPINAL FUSION, THE PIN FOR THE ADJUSTABLE PERCUTANEOUS FRAME WOULD NOT SECURE TO THE FRAME. THE LOOSE FRAME IS SUSPECTED TO HAVE LED TO AN IMPRECISION OF 1 MM OCCURRING DURING THE PROCEDURE. THE IMPRECISION WAS REPORTED AFTER PERFORM A 3D IMAGE ACQUISITION ON A MEDTRONIC IMAGING SYSTEM. TESTING FOUND THE IMAGING SYSTEM AND NAVIGATION SYSTEM FUNCTIONED AS DESIGNED, RESULTING IN THE FRAME BEING THE SUSPECT PROBABLE CAUSE OF THE IMPRECISION. THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITHOUT THE USE OF THE IMAGING SYSTEM. THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITHOUT THE USE OF THE NAVIGATION SYSTEM. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR 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 6672134 ↗
• MalfunctionJun 9, 2017Material Deformation; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINAL FUSION, THE REFERENCE FRAME FRACTURED WHEN ATTEMPTING TO SEAT IT ONTO THE PIN. THE SITE CONTINUE THE PROCEDURE WITH A SEPARATE FRAME. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR 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 6631045 ↗
• MalfunctionJun 2, 2017Material Deformation; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE SPRING FOR THE PERC PIN WAS LOOSE. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 6607876 ↗
• MalfunctionMay 22, 2017Material Deformation; Unintended Movement; Material Deformation; Unintended Movement

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINE PROCEDURE, THE SITE'S PERCUTANEOUS REFERENCE CROSS PIN FRAME WAS UNSTABLE AND WOBBLED WHEN IT WAS MOUNTED. THE SITE CHECKED THE FRAME AND SUSPECTED THAT THE SPRING OF THE LOCKING PART WAS BENT. NO FURTHER DETAILS REGARDING THIS ISSUE, OR SPECIFICALLY WHEN IT OCCURRED, WERE PROVIDED. IMMEDIATELY, THE SPINOUS PROCESS WAS IDENTIFIED, AND USING A SPINE FRAME, THE PROCEDURE WAS CONTINUED. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. DELAY IN THERAPY WAS LESS THAN ONE HOUR. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6583588 ↗
• MalfunctionMar 30, 2017Mechanical Problem; Device Operates Differently Than Expected; Mechanical Problem; Device Operates Differently Than Expected

  A SITE REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE SITE HAD A PERC PIN REFERENCE FRAME THAT WAS DAMAGED. IT WAS REPORTED THAT THE DAMAGE WAS RELATED TO THE SPRING WITHIN THE FRAME NOT FUNCTIONING AS DESIGNED. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 6445728 ↗
• MalfunctionMar 29, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED THAT THE SPRING IN THE PERK PIN FRAME WAS NOT WORKING AND THE FRAME WAS LOOSE. NO PATIENT WAS PRESENT DURING THE TIME OF THE REPORTED INCIDENT.

  Patient problems: No Patient Involvement

  MAUDE report 6444226 ↗
• MalfunctionDec 20, 2016Mechanical Problem; Device Operates Differently Than Expected; Mechanical Problem; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED THAT PRIOR TO A PROCEDURE, THE SURGEON NOTICED A LOOSE SPRING IN THE PATIENT REFERENCE FRAME. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6189775 ↗