N/A 9733498Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00613994475169), received between May 2, 2017 and May 20, 2022 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2022Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE PEDICLE ACCESS KIT (PAK) NEEDLE BROKE FROM THE HANDLE WHILE IN USE. A SECOND NEEDLE WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14452960 ↗
• MalfunctionJun 16, 2021Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE NEEDLE SHEERED OFF AT THE HANDLE WHEN THE SURGEON HAD UNLOCKED THE GREEN LOCKING LEAVER AND WAS TWISTING TO REMOVE. THE SITE HAD TO USE COCKERS AROUND THE BROKEN HEAD TO CLAMP ONTO AND ROTATE OUT WORKING AS A MAKE SHIFT HANDLE.  THE BLUE HANDLE WITH 4 SPHERES BROKE OFF OF THE SHARP INNER SHAFT. THE HANDLE CAME OFF  INTACT, HOWEVER, THE WHITE PLASTIC CONNECTED TO THE SHARP INNER SHAFT BROKE INTO TWO (ALL PLASTIC RETRIEVED) AND THE BROKEN SHAFT WAS SHARP. IT WAS IMMEDIATELY EMPTIED INTO THE SHARPS CONTAINER. THERE WAS NO DELAY IN THE PROCEDURE AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12009017 ↗
• MalfunctionFeb 12, 2021Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED INTRA/PERI-OPERATIVELY OF A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT PEDICLE ACCESS KIT (PAK) NEEDLE WAS DAMAGED WHILE PULLING INSTRUMENT OUT FROM THE BONE. THE REPORTS THAT THE HIND END OF THE INSTRUMENT BECAME SEPARATED FROM THE REST OF THE INSTRUMENT. THERE WAS NO DELAY IN THE PROCEDURE AND NO IMPACT ON PATIENT OUTCOME. THE SITE WAS ABLE TO RETRIEVE THE BROKEN INSTRUMENT WITH A HEAVY CLAMP WITHOUT ANY ISSUES. THE LIKELY CAUSE OF THE ISSUE WAS DUE TO EXCESSIVE HAMMERING ON THE INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11324108 ↗
• MalfunctionDec 14, 2020Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A PROCEDURE. IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL STATING THAT THE 2 PACK NEEDLES BROKE DURING THE PROCEDURE BEING USED AS USUAL. THERE WAS NO DELAY TO THE PROCEDURE. NO IMPACT ON PATIENT OUTCOME. NO FURTHER INFORMATION RECEIVED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE REPORTED ISSUE OCCURRED DURING A SPINAL FUSION PROCEDURE. THERE WAS ONLY A FEW MINUTE DELAY IN THE CASE, THE TIME IT TOOK TO PICK UP 2 OTHER NEEDLES. THE INSTRUMENT DID BREAK INSIDE OF THE PATIENT ANATOMY AND ALL BROKEN PIECES WERE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11003434 ↗
• MalfunctionAug 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 NEEDLES WERE DAMAGED. IT WAS NOTED THAT THIS ISSUE WAS AS PRODUCT DESIGN FAILURE. IF ANY FORCE IS HAMMERED ONTO THE NEEDLE THE NEEDLE BREAKS WITHIN THE HANDLE AND NEEDS TO BE REPLACED. THERE WAS NO PATIENT HARM. THE NEEDLE AND TROCAR BROKE AT THE HANDLE, SO, THEY DID BREAK WHILST WITHIN THE PATIENT ANATOMY. THE PROBLEM WAS QUICKLY SOLVED BY USING PLIERS TO REMOVE BOTH THE NEEDLE AND TROCAR. AT NO TIME WAS THE NEEDLE OR TROCAR BROKEN WITHIN THE BONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10370042 ↗
• MalfunctionAug 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 NEEDLES WERE DAMAGED. IT WAS NOTED THAT THIS ISSUE WAS AS PRODUCT DESIGN FAILURE. IF ANY FORCE IS HAMMERED ONTO THE NEEDLE THE NEEDLE BREAKS WITHIN THE HANDLE AND NEEDS TO BE REPLACED. THERE WAS NO PATIENT HARM. THE NEEDLE AND TROCAR BROKE AT THE HANDLE, SO, THEY DID BREAK WHILST WITHIN THE PATIENT ANATOMY. THE PROBLEM WAS QUICKLY SOLVED BY USING PLIERS TO REMOVE BOTH THE NEEDLE AND TROCAR. AT NO TIME WAS THE NEEDLE OR TROCAR BROKEN WITHIN THE BONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10370014 ↗
• MalfunctionMay 13, 2020Output Problem; Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE NEEDLE COULD NOT BE FIXED IN THE HANDLE. THEY OPENED NEW ITEMS AND THE ISSUE WAS RESOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10051658 ↗
• MalfunctionOct 21, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED FOR SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE NEEDLE INTERCHANGEABLE T HANDLE LOCK WAS ENGAGED, AND THE T HANDLE CONTINUED TO SLIP OFF WHEN PRESSURE WAS APPLIED. LOCKING MECHANISM DID NOT HOLD. ANOTHER NEEDLE WAS OPENED, AND THE SAME ISSUE OCCURRED. THERE WAS A DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9213831 ↗
• InjurySep 6, 2018Imprecision; Material Deformation; Imprecision; Material Deformation

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT DURING THE NAVIGATE TASK OF A SACROILIAC AND THORACOLUMBAR PROCEDURE, THERE WAS AN ALLEGED INACCURACY DUE TO A DAMAGED NAVIGATED PEDICLE ACCESS NEEDLE (PAC). THE NAVIGATED PAC NEEDLE WAS USED FOR A L2-L4 POSTERIOR FIXATION "MIS VOYAGER PROCEDURE". THE PAC NEEDLE REGISTERED USING A PASSIVE SPINE FRAME. THE PAC NEEDLE WAS USED TO FIND THE APPROPRIATE GUIDEWIRE POSITION. AFTER INSERTION OF ALL 6 GUIDEWIRES THE NAVIGATED CANNULATED TAB DRIVER WAS USED. HAVING THE GUIDEWIRES IN PLACE AND FOLLOWING THE ACQUIRED PATH WITH THE NAVIGATED TAB DRIVER IT WAS ALLEGED THAT THE PATH WAS 2MM OFF THE ACTUAL TARGET PATH. AFTER ELIMINATING POSSIBLE ERRORS - THE NAV TAB AND NAV DRIVER SHOWED THE SAME PATH - A NEW PAC NEEDLE WAS USED. THAT SHOWED THAT THE FIRST PAC NEEDLE WAS FAULTY. THE SITE EXAMINED THE FAULTY PAC NEEDLE AND IT COULD BE SEEN THAT THE CANNULA WAS SITING LOOSELY IN THE HANDLE - WHICH EXPLAINED WHY THE SURGEON WAS ABLE TO REGISTER THE PAC NEEDLE - NOT PUTTING PRESSURE ON IT. HOWEVER AS SOON AS THE PAC NEEDLE WAS WITHIN TISSUE THE SURGEON WAS PUTTING PRESSURE ON IT AND THEREFORE SHOWED A DIFFERENT PATH ON

  Patient problems: Spinal Column Injury; Tissue Damage

  MAUDE report 7851626 ↗
• InjuryMay 2, 2017Break; Break

  A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A SPINAL FUSION PROCEDURE, THE PAK NEEDLE CANNULA BROKE OFF INSIDE THE PATIENT. THE SURGEON DRILLED IT OUT AND WAS ABLE TO PULL IT FROM THE PATIENT. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE.

  Patient problems: Iatrogenic Source; Tissue Damage

  MAUDE report 6539118 ↗