ACCULIF 800307Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327105919), received between Mar 31, 2016 and Dec 28, 2017 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 28, 2017Break; Detachment Of Device Component; Fracture; Fracture

  IT WAS REPORTED THAT; TOP OF PLUNGER BROKE OFF. UPDATE 12/19/2017: SURGEON PREFERS TO USE THIS INSTRUMENT WITH HIS TLIF PROCEDURES. SURGEON WAS NOT USING THIS INSTRUMENT WITH THE SAME BRAND IMPLANT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7150790 ↗
• MalfunctionMar 31, 2016Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; DURING TL FUNNEL BONE TAMP IMPACTION, THE MALUANLE PORTION OF TAMP WAS DAMAGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5537654 ↗