AVS NAVIGATOR 48394005Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327270648), received between Mar 7, 2017 and Feb 16, 2018 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2018Fracture; Device Operates Differently Than Expected; Noise, Audible; Fracture

  THE SURGEON REPORTED THAT A DISTRACTOR FAILED SUDDENLY DURING DISTRACTION, DURING A TLIF MINI INVASIVE L4 L5 SURGERY. THE SURGEON REPORTED HEARING A "CLACK" AND THOUGHT A PIECE BROKE INSIDE THE MECHANISM. THE MECHANISM DID NOT SEIZE. THE SURGEON WAS ABLE TO RETRACT THE INSTRUMENT TO REMOVE IT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7278677 ↗
• MalfunctionDec 28, 2017Break; Detachment Of Device Component; Fracture; Fracture

  IT WAS REPORTED THAT; HANDLE BROKE OFF OF INSTRUMENT AND PART OF IT IS STUCK IN THREAD.

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

  MAUDE report 7150884 ↗
• MalfunctionAug 28, 2017Break

  IT WAS REPORTED THAT; THIS DEVICE WAS USED AT AN EXTREME ANGLE UNDER EXCEEDING PRESSURE. UPDATE 8/2/2017: THE TIP BROKE.

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

  MAUDE report 6825873 ↗
• MalfunctionAug 28, 2017Break

  IT WAS REPORTED THAT: THIS DEVICE WAS USED AT AN EXTREME ANGLE UNDER EXCEEDING PRESSURE UPDATE (B)(6) 2017: THE TIP BROKE.

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

  MAUDE report 6825871 ↗
• MalfunctionMar 7, 2017Break; Fracture; Difficult to Open or Close; Fracture

  IT WAS REPORTED THAT; CENTRAL STERILE SERVICES OF THE CLINIC, REPORTED THAT "THE DISTRACTOR COULD NOT OPEN COMPLETELY, THE HANDLE BROKE INSIDE BY UNSCREWING IT DURING A MEDICAL PROCEDURE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6384168 ↗