nanOss Advanced Bone Graft Substitute 90-100-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00849777012393), received between May 27, 2026 and May 27, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (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.

• MalfunctionMay 27, 2026Use of Device Problem

  THE MANUFACTURER WAS MADE AWARE OF TWO SYNTHETIC GRAFTS FROM THE SAME LOT THAT WERE UTILIZED ON SEPARATE PATIENTS BEYOND THE EXPIRATION DATE IDENTIFIED ON THE PRODUCT PACKAGING ON 04/29/2026. THE ISSUE WAS IDENTIFIED VIA A PRODUCT USAGE FORM THAT WAS SUBMITTED TO THE MANUFACTURER, WHICH IDENTIFIED TWO 1CC SYNTHETIC GRAFTS THAT HAD SURPASSED THE LABELED EXPIRATION DATE. THE GRAFTS HAD A DOCUMENTED EXPIRATION DATE OF 04/09/2026 AND WERE IMPLANTED ON (B)(6) 2026. THE DISTRIBUTOR REPRESENTATIVE LISTED ON THE CHARGE SHEET WAS NOTIFIED OF THE COMPLAINT AND CONFIRMED THAT THERE WERE NO REPORTED DELAYS IN SURGERY AND NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THE USE OF THE EXPIRED GRAFTS. THE COMPLAINT GRAFTS WERE NOT RETURNED AS THEY REMAIN IMPLANTED IN THE PATIENTS. REPORT 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25300925 ↗
• MalfunctionMay 27, 2026Use of Device Problem

  THE MANUFACTURER WAS MADE AWARE OF TWO SYNTHETIC GRAFTS FROM THE SAME LOT THAT WERE UTILIZED ON SEPARATE PATIENTS BEYOND THE EXPIRATION DATE IDENTIFIED ON THE PRODUCT PACKAGING ON 04/29/2026. THE ISSUE WAS IDENTIFIED VIA A PRODUCT USAGE FORM THAT WAS SUBMITTED TO THE MANUFACTURER, WHICH IDENTIFIED TWO 1CC SYNTHETIC GRAFTS THAT HAD SURPASSED THE LABELED EXPIRATION DATE. THE GRAFTS HAD A DOCUMENTED EXPIRATION DATE OF 04/09/2026 AND WERE IMPLANTED ON (B)(6) 2026. THE DISTRIBUTOR REPRESENTATIVE LISTED ON THE CHARGE SHEET WAS NOTIFIED OF THE COMPLAINT AND CONFIRMED THAT THERE WERE NO REPORTED DELAYS IN SURGERY AND NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THE USE OF THE EXPIRED GRAFTS. THE COMPLAINT GRAFTS WERE NOT RETURNED AS THEY REMAIN IMPLANTED IN THE PATIENTS. REPORT 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25300780 ↗