N/A 9733457 (UDI 00613994335968)Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00613994335968), received between Oct 12, 2016 and Feb 13, 2025 — classified as 45 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (23 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 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT WAS BENT. NO PATIENT WAS PRESENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PROBABLE CAUSE OF THE DAMAGE WAS DUE TO EXCESSIVE FORCE BEING APPLIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21376033 ↗
• MalfunctionMar 1, 2024Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE INSTRUMENT HAD DEFORMATION AND WAS NOT ACCURATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18816522 ↗
• MalfunctionOct 26, 2023Mechanical Problem; Device Sensing Problem; Mechanical Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT IT WAS DIFFICULT TO REGISTER THE PROBE SO IT MAY BE BENT. THERE WAS NO IMPACT TO PATIENT'S OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18012059 ↗
• MalfunctionApr 6, 2023Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE ACCURACY OF THE CERVICAL PROBE IS POOR. THE PROCEDURE WAS COMPLETED USING A POINTER. THERE WAS NO PATIENT IMPACT AND NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16690479 ↗
• MalfunctionJun 14, 2022Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A CERVICAL SPINAL PROCEDURE. IT WAS REPORTED THAT THE INSTRUMENT TIP WAS DEFORMED. THERE WAS A NO REPORTED DELAY AND NO REPORTED IMPACT TO PATIENT OUTCOME. ADDITIONAL INFORMATION WAS LATER RECEIVED. IT WAS REPORTED THAT THE MOST LIKELY SUSPECTED CAUSE ACCORDING TO THE MANUFACTURER REPRESENTATIVE (REP) WAS THAT THE PROBE MIGHT HAVE BECOME BENT DURING PROBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14687376 ↗
• MalfunctionFeb 18, 2022Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM AND INSTRUMENTS BEING USED FOR A SPINAL PROCEDURE. IT WAS REPORTED THAT THE TIP WAS DEFORMED AND THERE WAS POOR ACCURACY. THE SURGERY WAS COMPLETED AFTER DISCONTINUING THE USE OF THE CERVICAL PROBE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13556973 ↗
• MalfunctionNov 10, 2021Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE TIP WAS BENT ON THE PROBE. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE CAUSE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12790335 ↗
• MalfunctionDec 16, 2020Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT INTRA-OPERATIVELY, IT WAS FOUND THAT THE SURGICAL PROBE WAS BENT. THE PROCEDURE WAS COMPLETED WITH CONTINUED USE OF THE NAVIGATION SYSTEM AND A NON-NAVIGATED PROBE. THE DEFORMATION WAS CAUSED BY HITTING SOMETHING. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR DUE TO THIS ISSUE LAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11023270 ↗
• MalfunctionMar 18, 2020Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A CERVICAL SPINE. IT WAS REPORTED THAT IT WAS DIFFICULT TO REGISTER THE CERVICAL PROBE BECAUSE IT HAD A DEFORMED TIP. THE CERVICAL PROBE WAS USED WHILE CHECKING THE POSITION WITH A NORMAL POINTER. THERE WAS NO REPORTED DELAY TO THE CASE. NO IMPACT ON PATIENT OUTCOME. ON 2020-FEB-24, IT WAS REPORTED THAT THE PROBE COULD STILL PASS VERIFICATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9849822 ↗
• MalfunctionMar 3, 2020Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A CERVICAL SPINE PROCEDURE. IT WAS REPORTED THAT THE PEDICLE PROBE WAS DEFORMED, BUT COULD BE VERIFIED. ANOTHER PROBE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY TO THE PROCEDURE AND NO IMPACT TO PATIENT OUTCOME AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 9780795 ↗
• MalfunctionFeb 18, 2020Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THE CERVICAL PROBE WAS DEFORMED. THIS ISSUE WAS NOTED OUTSIDE OF A PROCEDURE, AND THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THE DEFORMED PROBE WAS ABLE TO BE VERIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 9721041 ↗
• MalfunctionFeb 6, 2020Imprecision; Material Integrity Problem; Imprecision; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT IF THE CERVICAL PROBE WAS ROTATED WITHOUT MOVING THE TIP OF THE PROBE, THE IMAGE WOULD MOVE. BACK UP PRODUCTS WERE USED TO COMPLETE THE PROCEDURE. THIS ISSUE OCCURRED INTRAOPERATIVELY AND DID NOT CAUSE ANY SURGICAL DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED THE TIP OF THE PROBE WAS BENT WHICH MADE THE SCREEN MOVE. IT WAS NOTED THE BENT PROVE WAS STILL ABLE TO VERIFY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9676825 ↗
• MalfunctionJan 9, 2020Imprecision; Material Integrity Problem; Imprecision; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A CERVICAL SPINE PROCEDURE. IT WAS REPORTED THAT WHILE USING THE CERVICAL PROBE AFTER VERIFICATION, THERE WAS AN INACCURACY OF ABOUT 3 MILLIMETERS. WHEN CHECKING THE TIP OF THE CERVICAL PROBE, IT WAS DEFORMED, SO THE PROCEDURE WAS CONTINUED WITHOUT USING THE CERVICAL PROBE AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE. THERE WAS NO DELAY TO THE PROCEDURE. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9569626 ↗
• MalfunctionDec 31, 2019Material Integrity Problem; Material Integrity Problem

  ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE INDICATED THE ISSUE WAS DISCOVERED PRIOR TO A PROCEDURE BY THE CLINICAL SPECIALIST. IT WAS CLARIFIED THE PEDICLE PROBE WAS BENT COMING OUT OF THE TRAY. THE PROBE WAS NOT USED FOR THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9535917 ↗
• MalfunctionDec 13, 2019Imprecision; Material Integrity Problem; Imprecision; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A CERVICAL SPINAL PROCEDURE. THE TIP IF THE INSTRUMENT WAS DEFORMED. THERE WAS A REPORTED INACCURACY OF .5MM. THE SITE OPTED TO USE THE PROBE WITHOUT NAVIGATION. THERE WAS NO REPORTED DELAY AND NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9466174 ↗
• MalfunctionDec 11, 2019Imprecision; Material Integrity Problem; Imprecision; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED PRE-OPERATIVELY OF A CERVICAL THORAX POSTERIOR FIXATION PROCEDURE. IT WAS REPORTED THAT THERE WAS AN INACCURACY OF ABOUT 1 MM WHEN USING THE INSTRUMENT PROBE. THE ISSUE PERSISTED EVEN THOUGH VERIFICATION WAS PERFORMED AGAIN AND WAS POINTED THAT THE TIP OF THE INSTRUMENT WAS BENT. THE SITE COMPLETED THE PROCEDURE WITH THE KNOWN APPROXIMATE 1 MM OF INACCURACY. THERE WAS NO DELAY IN THE PROCEDURE AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9451524 ↗
• MalfunctionDec 2, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE SITE HAS A PEDICLE PROBE THAT WAS BENT DURING STERILE PROCESSING. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9396154 ↗
• MalfunctionNov 25, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THE TIP OF THE PEDICLE PROBE WAS BENT. THIS ISSUE WAS NOTED OUTSIDE OF A PROCEDURE, AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9370091 ↗
• MalfunctionNov 24, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE A PROCEDURE. IT WAS REPORTED THAT DURING SERVICING THE PRODUCT WAS DAMAGED IN APPEARANCE. THE TIP WAS BENT. THE DECISION WAS MADE TO NOT REPLACE THE PROBE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 9367278 ↗
• MalfunctionJul 29, 2019Material Integrity Problem; Material Integrity Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT EVEN THOUGH THE TIP OF THE PROBE WAS BENT, IT WAS STILL ABLE TO VERIFY ON THE SYSTEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8836964 ↗
• MalfunctionJul 23, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE. IT WAS REPORTED THAT 2.25 PEDICLE PROBE WAS DAMAGED. IT WAS NOTED THAT THE DAMAGE OCCURRED IN REPROCESSING. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Patient Involvement

  MAUDE report 8817622 ↗
• MalfunctionJun 18, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM WHILE OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE PEDICLE PROBE TIP WAS CHIPPED. THERE WAS NO PATIENT PRESENT WHEN THE ISSUE OCCURRED.

  Patient problems: No Patient Involvement

  MAUDE report 8706309 ↗
• MalfunctionJun 17, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE PEDICLE PROBE WAS BENT. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8704145 ↗
• MalfunctionApr 24, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE A PROCEDURE. IT WAS REPORTED THAT THE CERVICAL PROBE WAS DEFORMED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8547433 ↗
• MalfunctionApr 12, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION INSTRUMENT OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE PROBE HAD A DEFORMED TIP. DURING THE REGULAR INSPECTION, THE CERVICAL PROBE COULD BE VERIFIED, BUT IT WAS VISUALLY CONFIRMED THAT THE PROBE WAS BENT. SLIGHT INACCURACY WAS ALSO CONFIRMED IN THE BONE MODEL. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Patient Involvement

  MAUDE report 8508900 ↗