N/A 5584109Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00643169043671), received between Jul 12, 2021 and Jun 30, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2026Material Deformation

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR POSTERIOR SPINAL FUSION. IT WAS REPORTED THAT BOTH THE DRIVERS WERE STRIPPED DURING THE REMOVAL OR REVISION OF A PRIOR IMPLANT CASE. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED AS SCREWDRIVER WAS STRIPPED AND TWISTED AND NONE OF THE DRIVERS DIDN'T BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25662271 ↗
• MalfunctionJul 29, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER USED ON PATIENT HAVING SPINAL THERAPY FOR REVISION FOR NON-UNION. IT WAS REPORTED THAT DURING A REVISION PROCEDURE FOR NON-UNION, THE DRIVER WAS USED WHILE UPSIZING PEDICLE SCREWS TO RESCUE SCREWS. DURING SCREW INSERTION, THE DRIVER TIP BROKE OFF DUE TO STRESS AND SHEAR FORCE. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT AND DISCARDED, AND THE DRIVER WAS DISPOSED OF IN THE SHARPS BIN. THE DRIVER HAD BEEN PREVIOUSLY USED WITH NO ISSUES. THE DRIVER BROKE DUE TO THE HARD BONE AND THE NON-UNION WAS NOT DUE TO ANY PRIOR MEDTRONIC PRODUCT. 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 22640644 ↗
• MalfunctionJan 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A USER FACILITY (UF) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT WILL BE USED IN SPINAL SURGERY. IT WAS REPORTED THAT THE TIP OF THE DRIVER WAS BROKE OFF. THERE IS NO PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21237042 ↗
• MalfunctionJan 18, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A DEVICE USED FOR SPINAL THERA PY. IT WAS REPORTED THAT IT WAS NOTICED IN STERILE PROCESSING PRIOR TO RESTERILIZING SET THAT THE TIP OF THE SCREWDRIVER 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 21186458 ↗
• MalfunctionDec 9, 2024Break; 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 WHILE REMOVING THE SCREWS. THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS/SYMPTOMS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20876899 ↗
• MalfunctionNov 25, 2024Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR POSTERIOR LUMBAR FUSION. IT WAS REPORTED THAT THE DRIVER BROKE. 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 20770076 ↗
• MalfunctionAug 8, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING FEW DRIVERS USED FOR SPINAL THER APY. IT WAS REPORTED THAT THE DRIVERS BROKE. PRODUCT WILL BE RETURNED. THERE WAS NO PATIENT INVOLVEMENT/SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19940070 ↗
• MalfunctionJun 7, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING R EMOVAL OF HARDWARE IN A PATIENT WHO HAD UNDERWENT PREVIOUS SPINAL FUSION. IT WAS REPORTED THAT THE SOLERA DRIVER TIP BROKE WHILE TRYING TO REMOVE THE SET SCREW. 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 19481741 ↗
• MalfunctionOct 12, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCTS USED IN A REVISION SURGERY FOR BROKEN HARDWARE. IT WAS REPORTED THAT THE BONE WAS SO HARD, THAT IT CAUSED THE GEARSHIFT TO GET TWISTED ON ITS WORKING TIP AND THE DRIVERS WERE BROKEN. THERE ARE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15585438 ↗
• MalfunctionAug 23, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR A PATIENT UNDERGOING UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT, USING LARGE DIAMETER 7.5X55 SOLERA MAS SCREWS AND THE BONE DENSITY SNAPPED 3 DRIVERS WHEN TRYING TO IMPLANT THE SCREWS. THE TIP BROKE OFF BUT THEY USED THE SUCTION TO RETRIEVE IT. NO FRAGMENTS REMAINED IN THE PATIENT. THERE WAS NO DELAY IN PROCEDURE REPORTED AS A RESULT OF THIS EVENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED. THERE WAS NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT OF THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12352343 ↗
• MalfunctionJul 12, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH STENOSIS FOR SPINAL THERAPY. IT WAS REPORTED THAT THE TLIF INSERTER BROKE DURING INSERTION OF A TITAN TT IMPLANT. THE PART OF THE INSERTER THAT THREADS INTO THE CAGE BROKE DURING INSERTION. WE HAD TO USE A HOSPITAL INSTRUMENT TO GRAB AND UNTHREADED IT FROM THE CAGE IN ORDER TO GET IT OUT. THE SCREWDRIVER TIP BROKE DURING INSERTION OF AN ILIAC SCREW. THE BONE WAS SO HARD, THAT IT PUT A LOT OF TORQUE AND STRESS ON THE DRIVER. I DID NOT REALIZE THE DRIVER HAS SHEERED OFF UNTIL THE NEXT DAY WHEN I WAS PUTTING UP THE SET. THE TIP OF THE DRIVER REMAINS IN THE TULIP HEAD OF THE SCREW AND IS LOCKED IN PLACE BY THE ROD AND SET SCREW.  IT WAS REPORTED THAT THE FRAGMENT OF THE DRIVER WAS NOT REMOVED. IT IS INSIDE THE SCREW LOCKED IN PLACE BY THE ROD AND SET SCREW. NO ADDITIONAL INTERVENTION IS PLANNED OR WAS DONE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12148773 ↗