N/A 5584331Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169043657), received between Sep 16, 2021 and Jul 29, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50067018 ↗
• MalfunctionNov 5, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE 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 20607925 ↗
• MalfunctionDec 20, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED A SCREW USING A DRIVER IN AN UNKNOWN SPINAL THERAPY FOR SCOLIOSIS. IT WAS REPORTED THAT  THE DRIVER TOP SNAPPED OFF BECAUSE OF THE HARD BONE. THE PATIENT WAS NOT AFFECTED. THIS DRIVER HAD BEEN USED MULTIPLE TIMES BEFORE. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18361970 ↗
• MalfunctionMay 10, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING REVISION SURGERY FOR SPINAL THERAPY L3-S1 TLIF. IT WAS REPORTED THAT, THIS WAS A REVISION DUE TO DEGENERATIVE DISC DISEASES SO HAD TO UPSIZE LARGE DIAMETER SCREWS. ADDITIONAL TORQUE REQUIRED TO DRIVE THE SCREW IN AND BROKE THE DISTAL TIP. THERE WAS NO FRAGMENT OF BROKEN INSTRUMENT REMAINS IN PATIENT BODY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14347535 ↗
• MalfunctionDec 6, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T10-ILIAC REVIS ION OF A COMPETITIVE TITANIUM XLIF CAGE. IT WAS REPORTED THAT THE RMAS SCREWDRIVERS TIP (DISTAL END) BROKE OFF IN THE TULIP OF THE SCREW WHILE UPSIZING A SCREW AS THE BONE WAS HARD. THE DISTAL END OF THE EXTRACTOR HAS BENT WHEN USING A SLAP HAMMER ON THE EXTRACTOR AND A BONE TAMP TO REMOVE THE CAGE FROM THE PATIENT. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME REPORTED. THERE WERE NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12932165 ↗
• MalfunctionDec 6, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING T10-ILIAC REVIS ION OF A COMPETITIVE TITANIUM XLIF CAGE. IT WAS REPORTED THAT THE RMAS SCREWDRIVERS TIP (DISTAL END) BROKE OFF IN THE TULIP OF THE SCREW WHILE UPSIZING A SCREW AS THE BONE WAS HARD. THE DISTAL END OF THE EXTRACTOR HAS BENT WHEN USING A SLAP HAMMER ON THE EXTRACTOR AND A BONE TAMP TO REMOVE THE CAGE FROM THE PATIENT. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME REPORTED. THERE WERE NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12932164 ↗
• MalfunctionSep 16, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SPINAL PRODUCT USING A DRIVER IN A TLIF FOR A DDD. IT WAS REPORTED THAT THE DISTAL END OF THE SCREW DRIVER BROKE. THERE WAS NO FRAGMENT OF THE INSTRUMENT REMAINING IN THE PATIENT'S BODY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. THE SCREW DRIVER WAS BEING USED TO DRIVE A SCREW INTO HARD BONE WHEN IT BROKE. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12479666 ↗