PASS LP A02230250Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03613720212126), received between Dec 9, 2024 and Jan 19, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 19, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING PRIOR TO USE OF THE REPORTED PRODUCT. IT WAS REPORTED THAT, THE PROBLEM WAS NOTICED PRE OP THAT ONE OF THE TEETH IS BROKEN OFF. THERE WAS NO PATIENT INVOLVED DURING THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21187819 ↗
• MalfunctionJan 11, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA A USER REPORT REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE PATIENT WAS TREATED FOR REMOVAL OF MATERIAL AND ENLARGEMENT OF LUMBOSACRAL MOUNT AND 2 OUT OF 4 NOTCHES OF THE DRIVER BROKE ONE AFTER THE OTHER WHEN THE OLD CAPS WERE LOOSENED. ONLY ONE NOTCH COULD BE REMOVED WITH CERTAINTY AND IT WAS UNCERTAIN WHETHER THE SECOND NOTCH WAS REMOVED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21133019 ↗
• MalfunctionJan 11, 2025Break; Detachment of Device or Device Component; Material Deformation; Break; Detachment of Device or Device Component; Material Deformation

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVER 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 21132950 ↗
• MalfunctionDec 9, 2024Break; Failure to Align; Break; Failure to Align

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR PLF. IT WAS REPORTED THAT THE DRIVER WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE EVENT. THE TIP OF THE DRIVER WAS NOT ABLE TO FULLY CONNECT WITH SCREW HEADS. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20876100 ↗