Zyfix Spinal Facet Screw System X076-0020Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M697X07600201), received between Sep 14, 2023 and Sep 14, 2023 — classified as 1 malfunction.

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.

• MalfunctionSep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 8/16/2023. IT WAS REPORTED THAT A SYSTEM COMPRESSION SCREW WOULD NOT ATTAIN BONE PURCHASE WHEN ATTEMPTED TO BE IMPLANTED IN A SURGICAL PROCEDURE. THE COMPLAINANT STATED THAT THE DISTAL TIP OF THE IMPLANT SCREW WAS NOT AGGRESSIVE ENOUGH TO FUNCTION AS INTENDED. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT ASSOCIATED WITH THIS COMPLAINT. THE SURGEON ELECTED TO PERFORM A LAMINECTOMY DURING THE PROCEDURE INSTEAD OF UTILIZING AN ALTERNATE SYSTEM IMPLANT SCREW. THE COMPLAINT IMPLANT WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR ASSESSMENT, AS IT WAS DISCARDED AT THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17750290 ↗