N/A 8670055Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00721902300813), received between Dec 2, 2025 and Jul 31, 2026 — classified as 15 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50096591 ↗
• MalfunctionMay 13, 2026Detachment of Device or Device Component

  INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A SEXTANT USED FOR TRANSFORAMINAL LUMBAR INTERBODY FUSION THERAPY. IT WAS REPORTED THAT THE TAPER END OF THE SEXTANT IS SEPARATED. THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25157797 ↗
• MalfunctionApr 7, 2026Break; Degraded; Flaked

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION. IT WAS REPORTED THAT TAPPER END IS SEPARATED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FUR THER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE STATING THAT THE TIP OF THE TAP HAD BEEN WORN OFF AND CHIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24796499 ↗
• MalfunctionApr 4, 2026Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A TAP USED FOR SPINAL TH ERAPY. IT WAS REPORTED THAT THE TAPPER END OF THE TAP WAS SEPARATED AND TIP OF THE INSTRUMENT 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 24784861 ↗
• MalfunctionMar 13, 2026Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING DEVICES USED FOR SPINAL THERAPY. IT WAS REPORTED THAT DURING VARIOUS THORACOLUMBAR PROCEDURES, INSTRUMENT BREAKAGE OCCURRED INVOLVING THE TWO SEPARATE TAPS AND ONE SHAVER. NO FRAGMENTS REMAINED IN ANY PATIENT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24588461 ↗
• MalfunctionMar 13, 2026Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING DEVICES USED FOR SPINAL THERAPY. IT WAS REPORTED THAT DURING VARIOUS THORACOLUMBAR PROCEDURES, INSTRUMENT BREAKAGE OCCURRED INVOLVING THE TWO SEPARATE TAPS AND ONE SHAVER. NO FRAGMENTS REMAINED IN ANY PATIENT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24588440 ↗
• MalfunctionMar 13, 2026Break; Crack

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A TAP USED FOR OBLIQUE LATERAL INTERBODY FUSION (OLIF) THERAPY. IT WAS REPORTED THAT THE TIP OF THE TAP HAD CRACKED AND FRAGMENTED OVER MULTIPLE USES, RESULTING IN AN INSTRUMENT BREAK. 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 24588415 ↗
• MalfunctionMar 13, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT USED IN TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). IT WAS REPORTED THAT INSTRUMENT BROKEN. NO PATIENT WAS INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24587931 ↗
• MalfunctionFeb 26, 2026Mechanics Altered

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A TAP USED FOR SPINAL TH ERAPY. IT WAS REPORTED THAT THE TIP OF THE TAPPER WAS OPEN AND COULD NOT BE USED PRIOR TO THE TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) PROCEDURE. THE GUIDEWIRE COULD NOT THREAD THROUGH AND THE PRODUCT WAS USED BEFORE. 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 24465966 ↗
• MalfunctionFeb 10, 2026Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A DEVICE USED FOR TRANSFORAMINAL LUMBAR INTERBODY FUSION. IT WAS REPORTED THAT TIP OF TAPPER IS SPLIT. 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 24302511 ↗
• MalfunctionDec 22, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR TRANSFORAMINAL LUMBAR INTERBODY FUSION. IT WAS REPORTED THAT, THE END OF DRIVER WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23862047 ↗
• MalfunctionDec 11, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR TLIF PROCEDURE. IT WAS REPORTED THAT THE TAP WAS BROKEN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23786087 ↗
• MalfunctionDec 8, 2025Material Deformation; Material Deformation

  ON 2025-INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A DEVICE USED FOR T RANSFORAMINAL LUMBAR INTERBODY FUSION. IT WAS REPORTED THAT THE END OF THE TAP END WAS OPEN. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE TIP OF THE INSTRUMENT WAS BLUNT. THIS PRODUCT HAS BEEN USED BEFORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23742479 ↗
• MalfunctionDec 8, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A DEVICE USED FOR TRANSFORAMINAL LUMBAR INTERBODY FUSION IT WAS REPORTED THAT THE END WAS OPEN. 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 23740119 ↗
• MalfunctionDec 2, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED PRIOR TO USE. IT WAS REPORTED THAT THE END OF THE INSTRUMENT WAS OPEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23691201 ↗