RELIANCE 48361220Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327269062), received between May 31, 2016 and Oct 20, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2022Material Deformation; Material Deformation

  A COMPANY REPRESENTATIVE REPORTED THAT THE INNER SHAFT OF A RELIANCE AL INTEGRATED DISTRACTOR INSERTER DEFORMED AND JAMMED DURING USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FIVE-MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15642378 ↗
• MalfunctionApr 25, 2017Mechanical Problem; Device Operates Differently Than Expected; Mechanical Problem

  IT WAS REPORTED THAT; WHEN THREADING THE T HANDLE IS ALMOST COMPLETELY DOWN. THE THREADS WERE JUMPING THEREFORE NOT ADVANCING THE IMPLANT. I WASN'T ADVANCING WHILE INSERTING THE IMPLANT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6518664 ↗
• MalfunctionJul 11, 2016Break

  IT WAS REPORTED THAT THE INSTRUMENT BROKE WHILE INSERTING THE IMPLANT

  Patient problems: No Information

  MAUDE report 5783983 ↗
• MalfunctionMay 31, 2016Break; Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF THREADED T-HANDLE BROKE WHILE INSERTING IMPLANT TO THE INSERTER. NOTHING BROKE INSIDE THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5689204 ↗