N/A 7650091Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00613994302816), received between Dec 2, 2022 and May 3, 2026 — classified as 12 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. 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 3, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ANTERIOR SCOLIO SIS CORRECTION SPINAL THERAPY FOR SCOLIOSIS. IT WAS REPORTED THAT THE INSTRUMENT WAS BEING USED TO BREAK OFF A SET SCREW, IT GOT BROKE OFF WITH A SMALL METAL FRAGMENT FELL INTO THE WOUND. THE METAL FRAGMENT WAS REMOVED IMMEDIATELY, AND IT WAS REPORTED THAT NO FRAGMENT REMAINED IN THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED, NO ADDITIONAL TREATMENT OR ADDITIONAL SURGERY WAS PERFORMED DUE TO THE EVENT, AND THE PATIENT WAS REPORTED ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25062892 ↗
• MalfunctionNov 11, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A DRIVER USED FOR POSTER IOR FIXATION PROCEDURE. IT WAS REPORTED THAT THE DRIVER DID NOT HOLD SET SCREW. PRODUCT WAS USED PREVIOUSLY WITHOUT ANY MALFUNCTION. 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 23520210 ↗
• MalfunctionAug 29, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, DURING THE PROCEDURE OF INSERTION THE SETSCREW, THE MENTIONED SHAFT OF THE DRIVER BREAKS 2 CM BELOW THE HANDLE. PROCEDURE PERFORMED WAS PERCUTANEUOS SPONYLODESIS. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22920425 ↗
• MalfunctionMar 13, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN SPINAL PROCEDURE IN A PATIENT. IT WAS REPORTED THAT THE DRIVERS BROKE. THE KEYS ARE FROM THE LONGITUDE LUMBAR SYSTEM, BUT THEY WERE NOT USED IN A PROCEDURE BUT WERE CHECKED FOR WEAR INTERNALLY. WORN KEYS - NOT HOLDING THE BLOCKER, THE BLOCKER IS FALLING OFF THE KEY AND BECAUSE IT IS A PERCUTANEOUS SYSTEM THE KEY NEEDS TO FIX THIS BLOCKER. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21591790 ↗
• MalfunctionMar 13, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN SPINAL PROCEDURE IN A PATIENT. IT WAS REPORTED THAT THE DRIVERS BROKE. THE KEYS ARE FROM THE LONGITUDE LUMBAR SYSTEM, BUT THEY WERE NOT USED IN A PROCEDURE BUT WERE CHECKED FOR WEAR INTERNALLY. WORN KEYS - NOT HOLDING THE BLOCKER, THE BLOCKER IS FALLING OFF THE KEY AND BECAUSE IT IS A PERCUTANEOUS SYSTEM THE KEY NEEDS TO FIX THIS BLOCKER. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21591761 ↗
• MalfunctionFeb 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR POSTERIOR FIXATION. IT WAS REPORTED THAT THE INSTRUMENT IS BROKEN. 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 21289584 ↗
• MalfunctionJan 31, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN INSTRUMENT TO BE USED IN POST ERIOR FIXATION. IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN. 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 21281640 ↗
• MalfunctionJan 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING INSTRUMENTS USED IN THORACOLUMBAR SCREW, ROD AND CAGE INSERTION. IT WAS REPORTED THAT THE DEVICES BROKE. HIGH USE INSTRUMENTS BREAK MORE OFTEN. THERE WAS NO PATIENT INVOLVED IN THE EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21237139 ↗
• MalfunctionJan 23, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING INSTRUMENTS USED IN THORACOLUMBAR SCREW, ROD AND CAGE INSERTION. IT WAS REPORTED THAT THE DEVICES BROKE. HIGH USE INSTRUMENTS BREAK MORE OFTEN. THERE WAS NO PATIENT INVOLVED IN THE EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21216072 ↗
• MalfunctionNov 7, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL REGARDING A DRIVER USED FOR POSTERIOR FIXATION. IT WAS REPORTED THAT DRIVER WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20629781 ↗
• MalfunctionApr 27, 2024Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A SCREW RETAINING DRIVER USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE BREAK OFF T-HANDLE WAS FOUND BROKEN UPON SETUP FOR NEXT DAY CASES. EVENT OCCURRED DURING SERVICING. OLD DRIVER WAS USED IN MULTIPLE CASE OVER SEVERAL YEARS. 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 19198831 ↗
• MalfunctionDec 2, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER(HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A SET SCREW DRIVER USED IN A LUMBAR FUSION PROCEDURE. IT WAS REPORTED THAT DRIVER BROKE MID CASE. THE SET SCREW DRIVER BROKE WHILE BREAKING THE SET SCREWS OFF AT THE END OF THE CASE. PATIENT AND SURGEON INVOLVEMENT WAS CONFIRMED IN THIS EVENT. NO PATIENT COMPLICATION OCCURRED. PRE-OP DIAGNOSIS FOR THE PATIENT WAS THORACIC FRACTURE. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15902748 ↗