N/A 7480131Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00721902853579), received between Oct 5, 2020 and Jul 21, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Break” (11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVER WAS BROKEN DURING THE OPERATION. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE PROCEDURE IS SCOLIOSIS. IT BROKE OUTSIDE THE PATIENT, SO NO FRAGMENTS REMAINED IN THE PATIENT. THERE WAS NO DELAY IN THE PROCEDURE TIME. NO PROLONGED HOSPITALIZATION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22553144 ↗
• MalfunctionFeb 25, 2025Break; Mechanical Problem; Break; Mechanical Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA MANUFACTURER REPRESENTATIVE REGARDING TWO DRIVERS USED FOR SPINAL THERAPY. IT WAS REPORTED THAT ONE OF THE INTERNAL PRONGS OF PROVISIONAL DRIVER THAT HOLD THE SET SCREWS WAS BROKEN AND THUS UNABLE TO HOLD A SET SCREW AND THE RUBBER ON THE HANDLE OF BREAK OFF DRIVER WAS CRACKED AND THEREFORE UNABLE TO BE PROCESSED. THESE ITEMS WERE SENT TO MEDICAL ENGINEERING WITH NO EXPLANATION AS TO WHEN OR HOW THE CRACK IN THE BREAK-OFF DRIVER HAPPENED OR WHEN OR HOW THE BROKEN PROVISIONAL DRIVER WAS DISCOVERED. THERE IS NO PATIENT INVOLVED IN THIS EVENT. THERE IS NO FURTHER INFORMATION AVAILABLE REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21457065 ↗
• MalfunctionFeb 11, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING FEW INSTRUMENTS USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN. PRODUCTS WILL BE RETURNED. THERE WAS NO PATIENT INVOLVED IN THE EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21353798 ↗
• MalfunctionFeb 7, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A INSTRUMENT USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVER INNER PIECE THAT HOLDS THE SET SCREW BROKE OFF DURING PROVISIONAL TIGHTENING. THE PIECE WAS RECOVERED. NO ADVERSE EVENT OCCURRED TO THE PATIENT. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED. THIS PRODUCT HAS BEEN CONSIDERED AS DISCARDED BY THE ACCOUNT. THE TYPE OF PROCEDURE INVOLVED DURING THE EVENT WAS THORACOLUMBAR DECOMPRESSION AND FUSION CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21337355 ↗
• MalfunctionJan 30, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA A MEDTRONIC REPRESENTATIVE REGARDING INSTRUMENTS USED IN AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE PRODUCTS WERE BROKEN. THERE WAS NO PATIENT INVOLVED IN THE EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21271967 ↗
• MalfunctionJan 30, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA A MEDTRONIC REPRESENTATIVE REGARDING INSTRUMENTS USED IN AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE PRODUCTS WERE BROKEN. THERE WAS NO PATIENT INVOLVED IN THE EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21271956 ↗
• MalfunctionJan 18, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A USER FACILITY (UF) VIA MANUFACTURER REPRESENTATIVE REGARDING A SPINAL PRODUCT THAT WAS USED IN AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVERS WERE BROKEN, TORQUE LIMITING HANDLE WILL NOT TORQUE OUT AND SCREW FALLS OUT FROM DRIVER. THERE WAS NO PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED PRODUCTS WERE ALREADY USED BEFORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21186261 ↗
• MalfunctionOct 7, 2024Crack; Crack

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE BLUE HANDLE OF THE DRIVER WAS CRACKED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20381765 ↗
• MalfunctionJul 25, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING TWO DRIVERS USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE HAS BROKEN. ONE OF THE INNER PRONGS THAT HOLDS THE SET SCREW BROKE OFF. PRODUCTS WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE PROCEDURE INVOLVED WAS A THORACOLUMBAR FUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19825224 ↗
• MalfunctionJul 25, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING TWO DRIVERS USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE HAS BROKEN.  ONE OF THE INNER PRONGS THAT HOLDS THE SET SCREW BROKE OFF. PRODUCTS WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE PROCEDURE INVOLVED WAS A THORACOLUMBAR FUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19825186 ↗
• MalfunctionJul 10, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT. IT WAS REPORTED THAT THE INSTRUMENTS BROKE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19710269 ↗
• MalfunctionJul 1, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED PRIOR TO USE. IT WAS REPORTED THAT WHEN SETTING UP THE CASE NOTICED TIP ON DRIVER IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19642442 ↗
• MalfunctionMay 14, 2021Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR LUMBAR DE COMPRESSION, FUSION, AND INSTRUMENTATION DUE TO SPINAL STENOSIS. IT WAS REPORTED THAT DRIVER WOULD NOT HOLD ON TO SET SCREWS AS REQUIRED.  THERE WERE NO PATIENT SYMPTOMS/ COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11824152 ↗
• MalfunctionDec 7, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REGARDING NAVIGATION AND SPINAL INSTRUMENTS BEING USED INTRA-OPERATIVELY OF A SPINAL L4/5 STENOSIS PROCEDURE. IT WAS REPORTED THAT THE LEGACY RATCHET AND PROVISIONAL BREAK OFF. THE RATCHET HANDLE BROKE. THEY DID NOT BREAK INSIDE THE PATIENT ANATOMY. THERE WAS NO IMPACT ON THE PATIENT INCOME. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT ALL THREE INSTRUMENTS WERE ALL BROKEN. THE PROVISIONAL WOULD NO LONGER RETAIN THE BREAK OFF SCREWS. THE RATCHET HANDLES WERE NO LONGER WORKING. THE CAPS ON TOP FELL OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10962037 ↗
• MalfunctionOct 5, 2020Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SET- SCREW USING A DRIVER FOR A SPINAL DECOMPRESSION AND FUSION (INTRA-OP). IT WAS REPORTED THAT THE PROVISIONAL DRIVER WOULD NOT RETAIN A SET SCREW. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. THE PRE-OP DIAGNOSIS WAS SPINAL STENOSIS. THE LEVELS IMPLANTED WERE LEVEL 4/ 5. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

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

  MAUDE report 10625299 ↗