Certex Spinal Fixation System X067-0425Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M697X06704251), received between Apr 19, 2018 and Jun 20, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

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.

• MalfunctionJun 20, 2018Fracture; Fracture

  THE COMPLAINANT REPORTED THAT TWO CROSS CONNECTOR LOCKING DRIVERS WERE BROKEN AND REQUESTED TO RETURN THE BROKEN PARTS. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WERE NO KNOWN PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7622700 ↗
• MalfunctionApr 19, 2018Fracture; Fracture

  THE COMPLAINANT CONTACTED THE COMPANY TO REPORT A POSSIBLE COMPLAINT WITH A CERTEX CROSS CONNECTOR LOCKING DRIVER (PART # X067-0425). THE COMPLAINANT REPORTED THAT THE TIP OF THE DRIVER CRACKED OFF AND STAYED LODGED IN THE SET SCREW. THE INDIVIDUAL REPORTING THE COMPLAINT WAS PRESENT DURING THE SURGERY, HOWEVER, WAS UNABLE TO SEE THE DAMAGE AND WAS UNABLE TO CONFIRM IF A PORTION OF THE LOCKING DRIVER REMAINED IN THE SET SCREW. THERE WERE NO KNOWN COMPLICATIONS OR HARM DONE TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7444615 ↗