RELIANCE 48361630Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327269741), received between Aug 11, 2016 and Sep 30, 2016 — classified as 1 injury, 1 malfunction.

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

• MalfunctionSep 30, 2016Fracture; Material Integrity Problem; Break; Crack; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; DURING SURGERY A TEAR DROP CURETTE WAS BROKEN. AT THE BOTTOM OF THE TEARDROP, THE INSTRUMENT HAS BEEN CRACKED APART.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5991979 ↗
• InjuryAug 11, 2016Fracture; Particulates; Device Operates Differently Than Expected; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT: "PURPOSE OF SURGERY: CORRECTION OF KYPHOSIS WITH VERTEBRAL BODY FRACTURE. PROCEDURE: SCREW AND HOOK FIXATION: T9- ILIAC. DECOMPRESSION. PLIF: L2-S1. ROD FIXATION. CAGES WERE IMPLANTED IN EACH VERTEBRAL SPACE. THE SURGEON COMPLETED SURGICAL INCISION CLOSURE AFTER HE TOOK X-RAY OF FRONTAL AND SAGITTAL. BEFORE REPOSITIONING OF THE PATIENT, THE SURGEON RECHECKED X-RAY AND FOUND SOME PARTICLE. THE SURGEON OPEN SURGICAL INCISION AGAIN AND REMOVED THE PIECE OF THE CURETTE SUCCESSFULLY.

  Patient problems: Bone Fracture(s); No Known Impact Or Consequence To Patient

  MAUDE report 5869088 ↗