PASS LP A02210100Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03613720160175), received between May 1, 2024 and Feb 16, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL SCREW RE MOVAL PROCEDURE AT THE L4 LEVEL. IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE WHILE BEING USED TO FACILITATE THE REMOVAL OF AN IMPLANTED SCREW. THE INSTRUMENT WAS APPLIED TO THE TOP OF THE SCREW WITH DOWNWARD PRESSURE TO BACK THE SCREW OUT, WHICH REQUIRED A GREAT DEAL OF FORCE, AND THE TIP BROKE AS A RESULT. NO FRAGMENTS REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24342665 ↗
• MalfunctionFeb 11, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL SCREW REMOVAL PROCEDURE AT THE L4 LEVEL. IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE WHILE BEING USED TO FACILITATE THE REMOVAL OF AN IMPLANTED SCREW. THE INSTRUMENT WAS APPLIED TO THE TOP OF THE SCREW WITH DOWNWARD PRESSURE TO BACK THE SCREW OUT, WHICH REQUIRED A GREAT DEAL OF FORCE, AND THE TIP BROKE AS A RESULT. NO FRAGMENTS REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24312876 ↗
• MalfunctionJan 19, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR REMOVAL OF PEDICLE SCREWS. IT WAS REPORTED THAT, WHEN ATTEMPTING TO REMOVE IMPLANTED SCREWS, THE DISTAL TIP TORQUED AND RIPPED OFF. THE TIPS OF THE DRIVERS WERE BROKEN. THERE WAS NO FRAGMENT OF BROKEN INSTRUMENT REMAINS IN PATIENT BODY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21187838 ↗
• MalfunctionJan 19, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR REMOVAL OF PEDICLE SCREWS. IT WAS REPORTED THAT, WHEN ATTEMPTING TO REMOVE IMPLANTED SCREWS, THE DISTAL TIP TORQUED AND RIPPED OFF. THE TIPS OF THE DRIVERS WERE BROKEN. THERE WAS NO FRAGMENT OF BROKEN INSTRUMENT REMAINS IN PATIENT BODY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21187836 ↗
• MalfunctionMay 21, 2024Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT THE T20 SCREW NEAR BARREL, ATTACHING DRIVER PIECES TOGETHER IS STUCK/STRIPPED. IT CANNOT BE SCREWED BACK INTO TO STABILIZE THE DRIVER PIECES. 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 19356884 ↗
• MalfunctionMay 1, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OP DIAGNOSIS OF PATIENT WAS PROXIMAL JUNCTIONAL KYPHOSIS. IT WAS REPORTED THAT THE DEVICE WAS BROKEN. THE PEDICLE SCREWDRIVER WAS BEING USED TO EXPLANT PREVIOUSLY IMPLANTED SCREWS BY ENGAGING THE BASE OF THE SCREW, AND WITH DOWNWARD PRESSURE, BACK THE SCREWS OUT. WHEN ATTEMPTING TO ENGAGE AND REMOVE THE SCREW, THE DISTAL TIP OF THE DRIVER SHEARED OFF. A SECOND DRIVER WAS SUBSEQUENTLY USED TO COMPLETE THE EXPLANTATION.  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 19219296 ↗