VERTEX® Reconstruction System 6958824Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994354754), received between Sep 15, 2020 and Sep 15, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionSep 15, 2020Break; Break

  ON (B)(6) 2020, MPXR 751785 (REP, HCP, FOR): INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN INDICATION OF ATLANTOAXIAL DISLOCATION IN NEED OF OPEN REDUCTION BY POSTERIOR ATLANTOAXIAL DISLOCATION, ILIAC BONE GRAFTING AND FUSION PROCEDURE USED IN SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE HAS BROKEN. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FRAGMENTS IN THE PATIENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ON (B)(6) 2020, EMAIL (REP, HCP): ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE EVENT. IT WAS REPORTED THAT DURING SCREWING, THE SCREW SHAFT WAS BENT. THE PRODUCT COME IN CONTACT WITH THE PATIENT AND HALF OF THE SCREW ROD IMPLANTED TO THE VERTEBRAL BODY. THERE WAS A DELAY OF ABOUT 5 MINS IN OVERALL PROCEDURE TIME REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10533325 ↗