N/A 6971155Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885074309644), received between Aug 25, 2020 and Feb 10, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (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 18, 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.

• MalfunctionFeb 10, 2021Degraded; Mechanics Altered; Degraded; Mechanics Altered

  INFORMATION RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR A PATIENT UNDERGOING PROCEDURE OF ANTERIOR CERVICAL DISC REPLACEMENT. IT WAS REPORTED THAT, THE INSTRUMENT REPEATEDLY FAILED TO LOAD/RETAIN THE IMPLANT FOR INSERTION. IT WAS MENTIONED THAT, INSTRUMENT IS HEAVILY WORN. IT WAS MENTIONED THAT, THE PRODUCT CAME IN CONTACT WITH PATIENT. THERE WAS NO ADDITIONAL SURGERY PERFORMED NOR TIME DELAY REPORTED AS A RESULT OF THIS EVENT. IT WAS MENTIONED THAT, THERE WAS NO BROKEN FRAGMENT OF THE INSTRUMENT LEFT INSIDE THE PATIENT. THERE WERE NO SYMPTOMS TO PATIENT OR PHYSICIAN WERE REPORTED OR ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11307711 ↗
• MalfunctionAug 25, 2020Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT THAT OCCURRED DURING AN ANTERIOR ARTIFICIAL DISC REPLACEMENT SURGERY ON A PATIENT DIAGNOSED WITH CERVICAL DISC DISEASE. IT WAS REPORTED THAT FOR THE PROSTHESIS WITH A HEIGHT OF 5MM, THE PROSTHESIS HOLDER COULD NOT HOLD THE PROSTHESIS, AND ONLY 6MM PROSTHESIS COULD BE REPLACED INTRA-OPERATIVELY FOR IMPLANTATION. PRODUCT WILL BE RETURNED AND WILL BE REPLACED WITH A MEDTRONIC PRODUCT. NO PATIENT INJURY / COMPLICATION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10447185 ↗