General instrumentation IG021RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03662663037662), received between Dec 5, 2025 and Feb 13, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 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.

• InjuryFeb 13, 2026Device Dislodged or Dislocated; Material Twisted/Bent

  IT WAS REPORTED THAT INTRA-OPERATIVE PROBLEMS WITH A DISTRACTOR LED TO A VEIN RUPTURING, CAUSING THE PATIENT TO BLEED HEAVILY. THE DISTRACTOR BLADES DETACHED FROM THE DISTRACTOR BODY AND WERE LEFT IN THE WOUND; THEY WERE ABLE TO BE RETRIEVED. THE DISTRACTOR'S ADJUSTMENT KNOB WAS ALSO BENT SO THE DISTRACTOR WAS STUCK IN ITS POSITION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS IN STABLE CONDITION AFTER A ONE-HOUR DELAY.THIS IS REPORT TWO OF SIX FOR THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 24334632 ↗
• InjuryDec 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT A DISTRACTION FORCEPS BROKE WHEN INSERTED INTO THE INTERVERTEBRAL SPACE DURING A DOUBLE LUMBAR LEVEL PROCEDURE. THE BREAK OCCURRED AT THE SECOND LEVEL, AND RESULTED IN THE PROCEDURE BEING ABORTED AND WILL NEED TO BE COMPLETED AT A LATER DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23730151 ↗