SMARTGRAFT Granules 0114.101Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813954023830), received between Dec 15, 2025 and Dec 15, 2025 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 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.

• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS ADVERSE EVENT OCCURRED OUTSIDE OF THE U.S. HOWEVER, AS THERE IS A SIMILAR MARKETED DEVICE IN THE U.S., AN MDR IS BEING FILED. AT TIME OF COMPLAINT INITIATION, THE CUSTOMER REPORTED A DEHISCENCE WAS OBSERVED IN A PATIENT AFTER THE APPLICATION OF SMARTGRAFT IN COMBINATION WITH SMARTBRANE (NOT A COLLAGEN MATRIX, INC. PRODUCT) IN THE ANTERIOR AREA. NO FURTHER INFORMATION WAS PROVIDED AT THIS TIME. CUSTOMER LATER PROVIDED ADDITIONAL INFORMATION SURROUNDING THE INCIDENT. A GENERALLY HEALTHY FEMALE PATIENT UNDERWENT GUIDED BONE REGENERATION SURGERY ON (B)(6) 2023, IN WHICH THE SMARTGRAFT PRODUCT WAS UTILIZED FOR FILLING A "CUSTOMER-MADE TITANIUM MESH EXTRA-ORALLY" AND WAS COMBINED "WITH CROSS-LINKED HYALURONIC ACID AND AUTOLOGOUS BONE IN A 70%-30% RATIO. MEMBRANES WERE PLACED OVER THE MESH, PARTIALLY OVERLAPPING ONE ANOTHER. THE MEMBRANES USED WERE NOT A COLLAGEN MATRIX, INC. PRODUCT. THERE WERE NO COMPLICATIONS NOTED DURING THIS INITIAL PROCEDURE. A FOLLOW-UP VISIT WAS CONDUCTED ON (B)(6) 2023 AND A MESH EXPOSURE MEASURING 4MM WIDE WAS OBSERVED. NO SIGNIFICANT PAIN OR INFECTIONS REPORTED. SUPERFICIALIZATION OF SOME GRANULES OF THE GRAFTED MATERIAL WAS NOTED. INTERVENTAION REQUIRED A

  Patient problems: Inflammation

  MAUDE report 23812050 ↗