N/A 9733235Recalls & reported problems

Summary

The FDA's MAUDE database contains 206 adverse event reports that list this exact device (DI 00613994247872), received between Oct 17, 2016 and Jan 14, 2026 — classified as 3 injuries, 203 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (158 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Dec 4, 2024Open, Classified

   Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter.

   Z-1022-2025 · Root cause: Under Investigation by firm · FDA record ↗

2. Nov 28, 2023Open, Classified

   Their is the potential that the percutaneous pin may have a cross-pin that may render the pin unable to fit into tap cap, or too tight to remove.

   Z-0698-2024 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 206 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2026Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT DURING A POSTERIOR LUMBAR FUSION, THE PERC PIN SIDE PIN DID NOT FIT INTO THE IMPACTION CAP. TWO PERC PINS FROM THE SAME LOT HAD THIS ISSUE. THE CLINICAL SPECIALIST (CS) FOUND A PERC PIN FROM A DIFFERENT LOT AND DID NOT ENCOUNTER THIS ISSUE. THERE WAS A LESS THAN ONE HOUR SURGICAL DELAY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24073411 ↗
• MalfunctionJan 14, 2026Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT DURING A POSTERIOR LUMBAR FUSION, THE PERC PIN SIDE PIN DID NOT FIT INTO THE IMPACTION CAP. TWO PERC PINS FROM THE SAME LOT HAD THIS ISSUE. THE CLINICAL SPECIALIST (CS) FOUND A PERC PIN FROM A DIFFERENT LOT AND DID NOT ENCOUNTER THIS ISSUE. THERE WAS A LESS THAN ONE HOUR SURGICAL DELAY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24073406 ↗
• MalfunctionJan 8, 2026Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE REFERENCE FRAME DID NOT FIT OVER THE PERC PIN PROPERLY AND WAS NOTED TO BE TOO SMALL. THE SITE USED A DIFFERENT PERC PIN TO BYPASS THE ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME. THE LENGTH OF DELAY IN THE PROCEDURE WAS UNKNOWN (B)(6) 2026 IUD (REP): ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS NO DELAY IN THE LENGTH OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24011811 ↗
• MalfunctionNov 25, 2025Material Fragmentation; Material Fragmentation

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT WHEN INSERTING THE PERC PIN, IT BROKE OFF. THE SITE REMOVED IT AND PROCEEDED WITH A NEW PERC PIN. THIS ISSUE CAUSED LESS THAN 1 HOUR SURGICAL DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645720 ↗
• MalfunctionJun 6, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THERE WAS AN ISSUE REGARDING A PERC PIN DURING SURGERY, AS THE INSTRUMENT WAS DEFECTIVE. WHEN ATTEMPTING TO INSERT THE PERC PIN INTO THE REFERENCE FRAME, THE MANUFACTURER REPRESENTATIVE STATED THAT THE SIDE ADAPTER WAS TOO LARGE TO FIT. AS A RESULT, A DIFFERENT PERC PIN WAS BROUGHT IN AND WAS INSERTED WITHOUT ISSUE. THERE WAS LESS THAN AN HOUR DELAY TO THE PROCEDURE AND NO IMPACT TO PATIENT OUTCOME. IT WAS CONFIRMED HOW THE INSTRUMENT GOT DAMAGED. THE PERC PIN WAS NOT DAMAGED DURING THE CASE, AND IT APPEARED THE PIN WAS MANUFACTURED INCORRECTLY AS THE SIDE ADAPTER WAS TOO LARGE TO FIT OVER THE SLOTS OF THE CROSS PIN TAP CAP AS WELL AS THE PERCUTANEOUS REFERENCE CROSS PIN FRAME. THE ¿DEFECT¿ WAS NOTICED BY THE PHYSICIAN WHEN HE ATTEMPTED TO PLACE THE PIN ON THE CAP BEFORE IT W AS INSERTED INTO THE PATIENT AT THE VERY BEGINNING OF THE TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22158805 ↗
• MalfunctionDec 4, 2024Material Fragmentation; Material Fragmentation

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SITE "PUT THE PERCUTANEOUS PIN IN BUT IT BROKE IN HALF INSIDE THE PATIENTS' PELVIS". SITE WAS ABLE TO REMOVE THE BROKEN FRAGMENT FROM THE PATIENTS' PELVIS. THIS RESULTED IN A SURGICAL DELAY OF LESS THAN ONE HOUR. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20841758 ↗
• MalfunctionOct 10, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE PERC PIN DID NOT FIT IN THE REFERENCE FRAME. THE DIAMETER OF PIN WAS TOO LARGE. THERE WAS NO DELAY TO THE PROCEDURE. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20417720 ↗
• MalfunctionOct 8, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE PERCUTANEOUS PIN DID NOT FIT IN THE SLOT IF THE TAP CAP. THE SITE COMPLETED THE PROCEDURE WITH A PERC PIN FROM A DIFFERENT LOT NUMBER. THERE WAS A DELAY OF LESS THAN ONE HOUR. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED 3 OUT OF 9 WERE TESTED AND SHOWED SAME ISSUE. 6 WERE NO FURTHER TESTED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE TAP CAP FIT, BUT THE PERC PIN DID NOT FIT IN THE REFERENCE FRAME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20398009 ↗
• MalfunctionOct 8, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE PERCUTANEOUS PIN DID NOT FIT IN THE SLOT IF THE TAP CAP. THE SITE COMPLETED THE PROCEDURE WITH A PERC PIN FROM A DIFFERENT LOT NUMBER. THERE WAS A DELAY OF LESS THAN ONE HOUR. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED 3 OUT OF 9 WERE TESTED AND SHOWED SAME ISSUE. 6 WERE NO FURTHER TESTED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE TAP CAP FIT, BUT THE PERC PIN DID NOT FIT IN THE REFERENCE FRAME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20397930 ↗
• MalfunctionOct 8, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE PERCUTANEOUS PIN DID NOT FIT IN THE SLOT IF THE TAP CAP. THE SITE COMPLETED THE PROCEDURE WITH A PERC PIN FROM A DIFFERENT LOT NUMBER. THERE WAS A DELAY OF LESS THAN ONE HOUR. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED 3 OUT OF 9 WERE TESTED AND SHOWED SAME ISSUE. 6 WERE NO FURTHER TESTED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE TAP CAP FIT, BUT THE PERC PIN DID NOT FIT IN THE REFERENCE FRAME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20397853 ↗
• MalfunctionOct 8, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE PERCUTANEOUS PIN DID NOT FIT IN THE SLOT IF THE TAP CAP. THE SITE COMPLETED THE PROCEDURE WITH A PERC PIN FROM A DIFFERENT LOT NUMBER. THERE WAS A DELAY OF LESS THAN ONE HOUR. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED 3 OUT OF 9 WERE TESTED AND SHOWED SAME ISSUE. 6 WERE NO FURTHER TESTED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE TAP CAP FIT, BUT THE PERC PIN DID NOT FIT IN THE REFERENCE FRAME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20397828 ↗
• MalfunctionOct 8, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE PERCUTANEOUS PIN DID NOT FIT IN THE SLOT IF THE TAP CAP. THE SITE COMPLETED THE PROCEDURE WITH A PERC PIN FROM A DIFFERENT LOT NUMBER. THERE WAS A DELAY OF LESS THAN ONE HOUR. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED 3 OUT OF 9 WERE TESTED AND SHOWED SAME ISSUE. 6 WERE NO FURTHER TESTED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE TAP CAP FIT, BUT THE PERC PIN DID NOT FIT IN THE REFERENCE FRAME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20397601 ↗
• MalfunctionOct 8, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE PERCUTANEOUS PIN DID NOT FIT IN THE SLOT IF THE TAP CAP. THE SITE COMPLETED THE PROCEDURE WITH A PERC PIN FROM A DIFFERENT LOT NUMBER. THERE WAS A DELAY OF LESS THAN ONE HOUR. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED 3 OUT OF 9 WERE TESTED AND SHOWED SAME ISSUE. 6 WERE NO FURTHER TESTED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE TAP CAP FIT, BUT THE PERC PIN DID NOT FIT IN THE REFERENCE FRAME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20397536 ↗
• MalfunctionOct 8, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE PERCUTANEOUS PIN DID NOT FIT IN THE SLOT IF THE TAP CAP. THE SITE COMPLETED THE PROCEDURE WITH A PERC PIN FROM A DIFFERENT LOT NUMBER. THERE WAS A DELAY OF LESS THAN ONE HOUR. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED 3 OUT OF 9 WERE TESTED AND SHOWED SAME ISSUE. 6 WERE NO FURTHER TESTED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE TAP CAP FIT, BUT THE PERC PIN DID NOT FIT IN THE REFERENCE FRAME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20397488 ↗
• MalfunctionOct 3, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THE INTERNAL CANNULA WAS TOO WIDE TO FIT IN EXTERNAL SLEEVE. THE PIN WOULD NOT FIT. THERE WAS NO DELAY AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20357988 ↗
• MalfunctionAug 21, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE PERCUTANEOUS PIN WOULD NOT FIT THE ADAPTER. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20022038 ↗
• MalfunctionAug 21, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE PERCUTANEOUS PIN WOULD NOT FIT THE ADAPTER. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20021582 ↗
• MalfunctionAug 21, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE PERCUTANEOUS PIN ADAPTER WOULD NOT FIT OVER THE HEAD OF THE PERC PIN. THE SITE FOUND THIS BEFORE PLACING IT IN PATIENT, THEY OPENED NEW PERC PIN TO CONTINUE WITH SURGERY. THERE WAS NO DELAY AND NO IMPACT ON THE PATIENT'S OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20021526 ↗
• MalfunctionAug 21, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE PERCUTANEOUS PIN WOULD NOT FIT THE ADAPTER. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20021005 ↗
• MalfunctionAug 21, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE PERCUTANEOUS PIN WOULD NOT FIT THE ADAPTER. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20020477 ↗
• MalfunctionJul 24, 2024Mechanical Problem; Mechanical Problem

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS A DELAY OF LESS THAN 5 MINUTES AS A DIFFERENT PIN WAS PULLED AND USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19817847 ↗
• MalfunctionJul 17, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE PERCUTANEOUS (PERC) PIN THEY HAD FOR A CASE WAS TOO THICK TO FIT IN THE RECEIVER OF THE PERC PIN FRAME. AFTER THE ACCOUNT USED EXCESSIVE FORCE TO GET THE FRAME ON, THEY MANAGED TO GET THE FRAME OFF BUT DISCARDED THE PIN AFTER USE AND KEPT THE FRAME HOLDER. THE SITE REPLACED THE PIN TO CONTINUE THE CASE. THE MANUFACTURER REPRESENTATIVE ARRIVED ON SITE TO AND FOUND A PERC PIN WITH THE SAME LOT NUMBER AS THE REPORTED PERC PIN; HOWEVER, THE FRAME HOLDER FIT ONTO THE PIN WITHOUT ISSUE. IT WAS REPORTED THAT THE HOSPITAL WAS TESTING THE PIN'S J-HOOK BEFORE IMPLANTING IT ON THE PATIENT UNTIL FURTHER NOTICE. THERE WAS NO IMPACT TO PATIENT'S OUTCOME AND THERE WAS NO SURGICAL DELAY TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19766686 ↗
• MalfunctionJul 2, 2024Fitting Problem; Fitting Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT DIAMETER OF THE PERCUTANEOUS PIN WAS TOO LARGER FOR THE FRAME ADAPTER TO FIT OVER IT. IT WAS NOT THE SIDE NUB BUT THE ACTUALLY DIAMETER OF THE PIN ITSELF. THE TAP CAP AND SLAP HAMMER STILL FIT. THE SURGEON JUST USED ANOTHER PIN WITH NO ISSUE. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME AND A REPORTED DELAY OF LESS THAN ONE HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19657769 ↗
• MalfunctionJun 30, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT  THE PERC PIN WOULD NOT FIT THE ADAPTER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19641048 ↗
• MalfunctionJun 30, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE PERC PIN WOULD NOT FIT THE ADAPTER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19641028 ↗