NA 390016Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327095180), received between May 31, 2018 and May 31, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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.

• MalfunctionMay 31, 2018Device Operates Differently Than Expected

  WHEN IMPLANTING A PARTIAL THREAD 6.5 CANNULATED SCREW IN A SI JOINT WITH A WASHER THE HEAD OF THE SCREW PASSED THROUGH WASHER PRIOR TO FINISHED POSITION. THEN DID IT AGAIN ON THE OTHER SIDE. THE WASHERS WERE REMOVED AND THE SCREWS LEFT IN PLACE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7558618 ↗
• MalfunctionMay 31, 2018Device Operates Differently Than Expected

  WHEN IMPLANTING A PARTIAL THREAD 6.5 CANNULATED SCREW IN A SI JOINT WITH A WASHER THE HEAD OF THE SCREW PASSED THROUGH WASHER PRIOR TO FINISHED POSITION. THEN DID IT AGAIN ON THE OTHER SIDE. THE WASHERS WERE REMOVED AND THE SCREWS LEFT IN PLACE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7558612 ↗