N/A 5485900Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00643169064287), received between May 8, 2024 and Feb 4, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (4 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.

• MalfunctionFeb 4, 2026Material Deformation

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INNER THREADS OF THE EXTENDER REDUCTION TOWER WERE STRIPPED, AND INSTRUMENT BREAKAGE OCCURRED, RENDERING THE REDUCTION TOWER UNUSABLE. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS ONLY STRIPPED. THE DEVICE WAS USED NUMEROUS TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24255922 ↗
• MalfunctionDec 15, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT DURING A POSTERIOR SPINAL FUSION PROCEDURE UTILIZING ADVANCED DEFORMITY INSTRUMENTS (ADIS) TO FACILITATE REDUCTION OF A 6.0 COCR ROD INTO PEDICLE SCREWS AT LEVELS T3 TO L4, ONE ADI FRACTURED DURING THE TIGHTENING PROCESS AS THE REDUCER WAS BEING SECURED TO THE PEDICLE SCREWS. A FRAGMENT OF THE INSTRUMENT WAS TEMPORARILY RETAINED AND IDENTIFIED INTRAOPERATIVELY. INTRAOPERATIVE X-RAY IMAGING WAS CONDUCTED TO LOCATE THE FRACTURED FRAGMENT, WHICH WAS SUBSEQUENTLY REMOVED PRIOR TO WOUND CLOSURE. THE PROCEDURE WAS ULTIMATELY SUCCESSFUL, AND NO FURTHER COMPLICATIONS WERE REPORTED ASIDE FROM THE ADDITIONAL OPERATIVE TIME AND IMAGING. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE TOTAL PROCEDURE TIME WAS EXTENDED BY APPROXIMATELY 20 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23800278 ↗
• MalfunctionDec 2, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING EXTENDERS. IT WAS REPORTED THAT THE DISTAL TIP WAS BROKEN ON ONE SIDE OF EXTENDER. NO PATIENT WAS ASSOCIATED WITH THIS EVENT, AND NO FRAGMENTS REMAINED IN A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692097 ↗
• MalfunctionDec 2, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING EXTENDERS. IT WAS REPORTED THAT THE DISTAL TIP WAS BROKEN ON ONE SIDE OF EXTENDER. NO PATIENT WAS ASSOCIATED WITH THIS EVENT, AND NO FRAGMENTS REMAINED IN A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692059 ↗
• MalfunctionJul 24, 2025Naturally Worn; Naturally Worn

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A EXTENDER USED IN DEFORMITY CORRECTION. IT WAS REPORTED THAT EXTENDER WAS USED TO THREAD INNER PIECE AND INNER PIECE WAS GETTING 'CAUGHT' AND IT WAS UNABLE TO THREAD ALL THE WAY DOWN TO REDUCE ROD. THERE WAS A SMALL SPUR ON INNER THREADS OF EXTENDER, MAKING IT IMPOSSIBLE TO THREAD INNER PIECE ALL THE WAY DOWN. LEVELS IMPLANTED WAS T3-L1. PRE-OPERATIVE DIAGNOSIS FOR THIS PATIENT WAS SCOLIOSIS. NO ADVERSE EVENT OCCURRED TO PATIENT. PRODUCT WAS WORN AND LIKELY OCCURRED FROM REPETITIVE USE OVER SEVERAL YEARS. EVENT WAS POINTED OUT ON BACK TABLE, BUT IDENTIFICATION OF MALFUNCTION WAS NOTICED IN SURGICAL FIELD. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22585479 ↗
• MalfunctionFeb 18, 2025Degraded; Mechanical Problem; Degraded; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING DECOMPRESSION AND INSTRUMENTED FUSION SPINAL THERAPY FOR SCOLIOSIS. LEVELS IMPLANTED WAS T4-PELVIS. IT WAS REPORTED THAT DURING A PROCEDURE THERE WAS AN ISSUE WITH THE DEVICES THAT ONE OF THE TABS ON EACH EXTENDER HAD WORN DOWN TO THE POINT OF NOT HOLDING ONTO THE HEAD OF THE SCREW ADEQUATELY, CAUSING IT TO POP OFF DURING USE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT. NO ADDITIONAL TREATMENT OR SURGERY WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21397820 ↗
• MalfunctionDec 13, 2024Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT, ONE OF THE TWO PRONGS ON THE SINGLE SIDED REDUCER IS NO LONGER INTACT MAKING IT UNABLE TO WORK PROPERLY ON THE HEAD OF THE SCREW. THE PRONG WAS BROKEN. REDUCER WAS USED FOR POSTERIOR SPINAL FIXATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20922944 ↗
• MalfunctionJun 2, 2024Defective Device; Mechanical Jam; Defective Device; Mechanical Jam

  INFORMATION WAS RECEIVED FROM A MEDTRONIC REPRESENTATIVE REGARDING INSTRUMENTS TO BE USED IN AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT DURING THE EXECUTION OF TEST, THE REP NOTICED THAT KEY COMPONENTS WERE NOT MATING TOGETHER PROPERLY. SPECIFICALLY, THE LEAD SCREW BECAME JAMMED/TOOK AN UNDUE AMOUNT OF TORQUE TO FULLY ACTUATE ON BOTH OPEN AND CLOSED REDUCERS. THE REP TRIED DIFFERENT LEAD SCREWS WITH DIFFERENT REDUCER BODIES, BUT CONSISTENTLY EXPERIENCED THE SAME FAILURE REGARDLESS. IT WAS ALSO NOTICED THAT DURING AN ADDITIONAL CHECK, REP WAS ABLE TO ENSURE THAT THE LEAD SCREWS FOR REDUCER PASSED REQUIRED GAGE CHECK, ALL 12 DID (INCLUDING THE 2 FUNCTIONAL FAILURES ONES).THERE WAS NO PATIENT INVOLVED IN THE EVENT. THE PARTS WERE DELIVERED DEFECTIVE. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19444620 ↗
• MalfunctionMay 8, 2024Defective Device; Mechanical Jam; Defective Device; Mechanical Jam

  INFORMATION WAS RECEIVED FROM A MEDTRONIC REPRESENTATIVE REGARDING INSTRUMENTS TO BE USED IN AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT DURING THE EXECUTION OF TEST, THE REP NOTICED THAT KEY COMPONENTS WERE NOT MATING TOGETHER PROPERLY. SPECIFICALLY, THE LEAD SCREW BECAME JAMMED/TOOK AN UNDUE AMOUNT OF TORQUE TO FULLY ACTUATE ON BOTH OPEN AND CLOSED REDUCERS. THE REP TRIED DIFFERENT LEAD SCREWS WITH DIFFERENT REDUCER BODIES, BUT CONSISTENTLY EXPERIENCED THE SAME FAILURE REGARDLESS. THERE WAS NO PATIENT INVOLVED IN THE EVENT. THE PARTS WERE DELIVERED DEFECTIVE. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19266949 ↗
• MalfunctionMay 8, 2024Defective Device; Mechanical Jam; Defective Device; Mechanical Jam

  INFORMATION WAS RECEIVED FROM A MEDTRONIC REPRESENTATIVE REGARDING INSTRUMENTS TO BE USED IN AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT DURING THE EXECUTION OF TEST, THE REP NOTICED THAT KEY COMPONENTS WERE NOT MATING TOGETHER PROPERLY. SPECIFICALLY, THE LEAD SCREW BECAME JAMMED/TOOK AN UNDUE AMOUNT OF TORQUE TO FULLY ACTUATE ON BOTH OPEN AND CLOSED REDUCERS. THE REP TRIED DIFFERENT LEAD SCREWS WITH DIFFERENT REDUCER BODIES, BUT CONSISTENTLY EXPERIENCED THE SAME FAILURE REGARDLESS. THERE WAS NO PATIENT INVOLVED IN THE EVENT. THE PARTS WERE DELIVERED DEFECTIVE. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19266941 ↗