N/A 6971156Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00721902991998), received between Dec 30, 2025 and Mar 12, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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.

• MalfunctionMar 12, 2026Mechanical Problem; Device Fell

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING CERVICAL DISC PROSTHESIS. IT WAS REPORTED THAT THE SPRING OF THE HOLDER JUMPED OUT DUE TO A WELD SEAM COMING LOOSE ISSUE, CAUSING THE INSTRUMENT TO FALL APART COMPLETELY. AS A RESULT, THE SURGERY DURATION WAS EXTENDED BY ONE HOUR LONGER THAN PLANNED, AND THE PATIENT REMAINED UNDER ANESTHESIA FOR AN ADDITIONAL HOUR. THE PROCEDURE INVOLVED A TWO-LEVEL IMPLANT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24577505 ↗
• MalfunctionDec 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A DEVICE USED FOR POSTER IOR FIXATION. IT WAS REPORTED THAT THE INSTUMENT DISASSEMBLED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23919537 ↗