N/A 8110540Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00721902766404), received between Feb 16, 2021 and Feb 16, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2021Naturally Worn; Naturally Worn

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH LUMBAR FIXATION AND FUSION DUE TO LUMBAR DEGENERATION. IT WAS REPORTED THAT THE CROSSLINK SCREW CAP WAS FOUND BROKEN DURING X-RAY BEFORE THE PATIENT WAS DISCHARGED FROM THE HOSPITAL, AND A PART OF THE SCREW CAP FELL ON THE EPIDURAL OF THE LUMBAR SPINE. THE NUT OF THE X10 CROSSLINK WAS ABNORMALLY BROKEN AND BROKE IN THE PATIENT'S BODY AFTER THE SURGERY. CROSSLINK REMAINS IMPLANTED. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11330943 ↗