Calix Spinal Implant System X034-0387Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M697X03403871), received between Jul 19, 2023 and Jul 19, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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 18, 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.

• MalfunctionJul 19, 2023Material Fragmentation; Material Fragmentation

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 6/19/2023. IT WAS REPORTED THAT A 26MM X 10MM X 6MM X 5° PLIF IMPLANT MALFUNCTIONED WHEN BEING PLACED DURING A PROCEDURE. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT ASSOCIATED WITH THIS COMPLAINT. THE MALFUNCTIONED IMPLANT WAS REMOVED, AND AN ALTERNATE AVAILABLE IMPLANT WAS SUCCESSFULLY UTILIZED TO COMPLETE THE SURGICAL PROCEDURE. THE COMPLAINT IMPLANT WAS DISCARDED AT THE SURGICAL FACILITY AND NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR ASSESSMENT. THE COMPLAINANT PROVIDED PHOTOS OF THE COMPLAINT IMPLANT, WHICH SHOWED THE PROXIMAL END THAT ENGAGES WITH THE SYSTEM INSERTER HAD FRACTURED FROM THE BODY OF THE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17355314 ↗