Implant Removal Tool IXTRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10841307119418), received between Apr 19, 2019 and Oct 4, 2021 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 4, 2021Fracture; Fracture

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PRODUCT BROKEN OR FRACTURED COMPONENT.

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis

  MAUDE report 12567441 ↗
• InjurySep 14, 2021Fracture; Fracture

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PRODUCT BROKEN OR FRACTURE WAS OBSERVED.

  Patient problems: Failure of Implant

  MAUDE report 12466944 ↗
• InjuryMar 31, 2020Positioning Problem; Positioning Problem

  PER (B)(4), DURING CLINICAL PROCEDURE, THE IMPLANT REMOVAL TOOL BROKE INSIDE THE IMPLANT WHILE ATTEMPTING TO REMOVE.

  Patient problems: Failure of Implant; No Information

  MAUDE report 9902346 ↗
• MalfunctionApr 19, 2019Fracture; Compatibility Problem; Fracture; Compatibility Problem

  PER COMPLAINT (B)(4), AN IMPLANT FAILED TO INTEGRATE AND WAS REMOVED. DURING THE EXTRACTION THE IXT TOOL BECAME STUCK WITHIN THE IMPLANT AND IT WAS FRACTURED.

  Patient problems: Failure of Implant; No Information

  MAUDE report 8530387 ↗