n/a 6550045Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000712020), received between Jun 24, 2025 and Oct 16, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2025Mechanical Problem; Contamination /Decontamination Problem; Mechanical Problem; Contamination /Decontamination Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A PATIENT HAVING SPINAL THERAP Y. IT WAS REPORTED THAT THE SIX GUIDES HAD THE CEMENT STUCK IN THE SLEEVE AND FOR THE FOUR GUIDES CEMENT STUCK INSIDE THE DEVICE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23307320 ↗
• MalfunctionOct 16, 2025Mechanical Problem; Contamination /Decontamination Problem; Mechanical Problem; Contamination /Decontamination Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE SIX GUIDES HAD THE CEMENT STUCK IN THE SLEEVE AND FOR THE FOUR GUIDES CEMENT STUCK INSIDE THE DEVICE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23307317 ↗
• MalfunctionOct 16, 2025Mechanical Problem; Contamination /Decontamination Problem; Mechanical Problem; Contamination /Decontamination Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE SIX GUIDES HAD THE CEMENT STUCK IN THE SLEEVE AND FOR THE FOUR GUIDES CEMENT STUCK INSIDE THE DEVICE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23307298 ↗
• MalfunctionJun 24, 2025Mechanical Problem; Use of Device Problem; Mechanical Problem; Use of Device Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ADULT DEFORMITY PROCEDURE FOR DEGENERATIVE DISCS, WHICH INCLUDED TLIF/PSIF AT LEVELS L1-S2AI. IT WAS REPORTED THAT THERE WERE FOUR GUIDES HAD ISSUES LIKE THE SLEEVES WERE NOT INSERTED COMPLETELY OVER THE SHANKS WHICH RESULTED IN CEMENT BACKFILLING THROUGH THE CANNULA. THESE PROCEDURAL ISSUES WERE IDENTIFIED AS NOT FOLLOWING THE INSTRUCTIONS FOR USE. NO PATIENT SYMPTOMS, COMPLICATIONS, ADVERSE EVENTS, OR INJURIES WERE REPORTED AND THE INSTRUMENTS WERE DISCARDED BY THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320716 ↗
• MalfunctionJun 24, 2025Mechanical Problem; Use of Device Problem; Mechanical Problem; Use of Device Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ADULT DEFORMITY PROCEDURE FOR DEGENERATIVE DISCS, WHICH INCLUDED TLIF/PSIF AT LEVELS L1-S2AI. IT WAS REPORTED THAT THERE WERE FOUR GUIDES HAD ISSUES LIKE THE SLEEVES WERE NOT INSERTED COMPLETELY OVER THE SHANKS WHICH RESULTED IN CEMENT BACKFILLING THROUGH THE CANNULA. THESE PROCEDURAL ISSUES WERE IDENTIFIED AS NOT FOLLOWING THE INSTRUCTIONS FOR USE. NO PATIENT SYMPTOMS, COMPLICATIONS, ADVERSE EVENTS, OR INJURIES WERE REPORTED AND THE INSTRUMENTS WERE DISCARDED BY THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320711 ↗