X90 Pedicle Screw System N60000328Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M697N600003281), received between Apr 24, 2019 and Apr 24, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (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 18, 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.

• MalfunctionApr 24, 2019Mechanical Jam; Mechanical Jam

  THE COMPLAINANT REPORTED THAT PEDICLE SCREWS WERE EXTREMELY DIFFICULT TO LOCK AND WHEN THE ROD IS SLIGHTLY BENT, THE SURGEON CANNOT LOCK THE SCREWS. THERE WERE NO KNOWN PATIENT COMPLICATIONS. THIS MDR CORRESPONDS WITH MDR 3005031160-2019-00022.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8547122 ↗
• MalfunctionApr 24, 2019Mechanical Jam; Mechanical Jam

  THE COMPLAINANT REPORTED THAT PEDICLE SCREWS WERE EXTREMELY DIFFICULT TO LOCK AND WHEN THE ROD IS SLIGHTLY BENT, THE SURGEON CANNOT LOCK THE SCREWS. THERE WERE NO KNOWN PATIENT COMPLICATIONS. THIS MDR CORRESPONDS WITH MDR 3005031160-2019-00021.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8547112 ↗