N/A 5584134Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169029170), received between Aug 19, 2020 and May 21, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2025Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED PRIOR TO USE. IT WAS REPORTED THAT THE EXTENDERS WERE BENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22059268 ↗
• MalfunctionAug 19, 2020Material Separation; Material Separation

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A REDUCER AND SCREWDRIVER USED IN LUMBAR REVISION POSTEROLATERAL FUSION WITH PELVIC FIXATION. LEVELS IMPLANTED L3, S2AI . IT WAS REPORTED THAT FOR THE REDUCER, THE SPRING IN BETWEEN THE HANDLE BROKE APART AS IT WAS BEING SQUEEZED AND FOR THE SCREWDRIVER - PATIENT HAD HARD CORTICAL BONE, AND SURGEON OPTS TO SWITCH STRAIGHT RATCHETING HANDLE TO RATCHETING T-HANDLE WHILE SCREW DRIVER ANDSCREW ARE STILL IN PATIENT. SURGEON TURNS HANDLE WITH A LOT OF FORCE AND THE DRIVER BREAKS APART AND DISCOVERED THE TIP OF THE DRIVER HAD BROKEN OFF AND FELL INTO THE PATIENT. THE TIP WAS IDENTIFIED AND EXTRACTED. NO OTHER PATIENT SYMPTOMS OR COMPLICATIONS REPORTED. MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTALS REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED INDICATES REPORTABLE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10424099 ↗