N/A 8880009Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885074226552), received between May 7, 2021 and Feb 24, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING AN INSTRUMENT USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSTRUMENT TIP BROKE OFF. THERE WAS NO PATIENT INVOLVED AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21444993 ↗
• MalfunctionApr 24, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PREOPERATIVE DIAGNOSIS FOR L1 VERTEBRAL FRACTURE. PROCEDURE PERFORMED WAS POSTERIOR FUSION FOR L1 FRACTURE. THE LEVEL AT WHICH THE IMPLANT PERFORMED WAS TH11-L3. IT WAS REPORTED THAT THE TORQUE LIMITING HANDLE WAS BROKEN DURING THE FINAL TIGHTENING. WHEN FINAL TIGHTENING WAS PERFORMED STARTING FROM THE RIGHT TEMPORAL SIDE, THE PRODUCT WAS BROKEN WHEN THE THIRD L2 WAS FINALLY TIGHTENED. AS A REPLACEMENT, THE FINAL TIGHTENING WAS DONE USING A MODULAR FIX HANDLE & TORQUE INDICATING DRIVER, AND THE OPERATION WAS COMPLETED WITHOUT ANY PROBLEMS. THERE WAS NO FRAGMENT LEFT INSIDE THE PATIENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. DELAY IN OVERALL PROCEDURE TIME WAS LESS THAN 60 MINUTES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19170485 ↗
• MalfunctionMay 7, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN INDICATION OF VERTEBRAL CANAL STENOSIS AT L5/S IN NEED OF L5/S TLIF USED IN SPINAL THERAPY. IT WAS REPORTED THAT WHEN RETIGHTENING SET SCREW WITH A DRIVER THAT COMBINED THE 815-518 SHAFT T25 AND THE 8880009 SO47 TORQUE LIMITING DRIVER, THE TIP OF THE BROKE DURING RETIGHTENING OF THE NON-BREAK SET SCREW OF SOLERA 4.75. THE BROKEN TIP WAS REMOVED FROM THE SURGICAL FIELD. THE EVENT WAS THOUGHT TO HAVE OCCURRED IN THE 4TH ONE OF FIXATION OF ONE INTERVERTEBRAL DISC. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FRAGMENTS IN THE PATIENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11789027 ↗