nexis® Ø7 XSD06003Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03700879509761), received between Jul 10, 2020 and Jul 10, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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 16, 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.

• InjuryJul 10, 2020Break

  SURGERY OF (B)(6) 2020, (B)(6). " INSTRUMENT BREAKAGE: OCCURRED AT THE END OF THE INTERVENTION WHEN THE SURGEON TRIED TO INSERT A SCREW HEAD IN A CORTEX. THE SURGERY WAS CARRIED OUT CORRECTLY EXCEPT FOR THE IMPLANTATION OF THE 3RD SCREW. THIS SCREW HAS NOT BEEN INSERTED ENOUGH, WHICH CAN ANNOY THE PATIENT. THE SURGEON USED ANOTHER INSTRUMENT TO REMOVE THE SCREW BUT IT WAS NOT POSSIBLE. A FOLLOW-UP IS DONE TO ENSURE THAT THE FULL ARTHRODESIS IS DONE. IN CASE OF THE THIRD SCREW HEAD IS TOO ANNOYING, A NEW SURGERY WILL BE PLANNED FOR REMOVAL OF IT. CUSTOMER COMPLAINT : (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 10257363 ↗