N/A 6550044Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000712013), received between Jun 24, 2025 and Dec 2, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT DOCTOR LOADED THE APPROPRIATE CEMENT BONE FILLERS AND ATTACHED THEM TO THE CEMENT INNER TUBES AND BEGAN TO INJECT CEMENT. SOON AFTER NOTICED A SMALL AMOUNT OF CEMENT LEAKING OUT OF THE OUTER SLEEVE AROUND THE SHANK HEAD. 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 23691434 ↗
• MalfunctionDec 2, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT DOCTOR LOADED THE APPROPRIATE CEMENT BONE FILLERS AND ATTACHED THEM TO THE CEMENT INNER TUBES AND BEGAN TO INJECT CEMENT. SOON AFTER NOTICED A SMALL AMOUNT OF CEMENT LEAKING OUT OF THE OUTER SLEEVE AROUND THE SHANK HEAD. 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 23691418 ↗
• MalfunctionDec 2, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT DOCTOR LOADED THE APPROPRIATE CEMENT BONE FILLERS AND ATTACHED THEM TO THE CEMENT INNER TUBES AND BEGAN TO INJECT CEMENT. SOON AFTER NOTICED A SMALL AMOUNT OF CEMENT LEAKING OUT OF THE OUTER SLEEVE AROUND THE SHANK HEAD. 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 23691401 ↗
• 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 23307297 ↗
• 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 23307290 ↗
• 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 23307158 ↗
• 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 23307156 ↗
• 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 23307153 ↗
• 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 23307151 ↗
• MalfunctionJun 24, 2025Mechanical Problem; Use of Device Problem; Mechanical Problem; Use of Device Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE WERE NO ALLEGATIONS WITH CEMENT AND THE ISSUE WAS THAT THE OUTER SLEEVES WERE NOT ENGAGED PROPERLY CAUSING THIS ACCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320681 ↗
• 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 22320583 ↗