OSSIX™ Bone 0.500 ccRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290015477253), received between Oct 11, 2022 and Oct 22, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (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. How this data works · Data updated Oct 13, 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.

• InjuryOct 22, 2025Failure to Osseointegrate; Failure to Osseointegrate

  IN THIS EVENT IT IS REPORTED THAT OSSIX BONE 5*10*10 (0.5 CC) WAS USED IN TREATMENT. CUSTOMER REPORTS THAT WHEN THE AREA WAS REOPENED AFTER 6 MONTHS, NO BONE FORMED. THE PRODUCT REMAINS SPONGY/RUBBERY. THIS IS A OSSEOINTEGRATION ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 23356382 ↗
• InjuryOct 11, 2022Use of Device Problem; Use of Device Problem

  A DOCTOR REPORTED THAT THEY REMOVED TEETH 15-16 AND PLACED OSSIX BONE IN A SOCKET PRESERVATION PROCEDURE. THE DOCTOR DID NOT HYDRATE THE MATERIAL PRIOR TO PLACEMENT. THE PATIENT INDICATED 3 DAYS POST PROCEDURE THAT THEY DEVELOPED SWELLING AND WERE PRESCRIBED AMOXICILLIN. AT THE ONE-WEEK POST-OP VISIT, THE DOCTOR NOTED SLIGHT SWELLING AND PRESCRIBED THE PATIENT MEDROL DOSE PACK. LATER THE PATIENT CALLED TO INDICATE THEIR JAW FELT STIFF AND THEY WERE PRESCRIBED CYCLOBENZAPRINE MUSCLE RELAXANT. THE PATIENT LATER DEVELOPED SWELLING AT THE ANGLE OF HER MANDIBLE AND WAS INSTRUCTED TO GO TO THE EMERGENCY ROOM BY TREATING DOCTOR. THE TREATING DOCTOR AT THE ER DIAGNOSED THE PATIENT WITH OSTEOMYELITIS AND THEY WERE REFERRED TO AN INFECTIOUS DISEASE SPECIALIST WHO PLACED THE PATIENT ON IV ANTIBIOTICS THERAPY FOR 2 DAYS. THE PATIENT RETURNED TO THE REPORTING OFFICE APPROXIMATELY ONE MONTH POST PROCEDURE TO BE SEEN BY THE MAXILLOFACIAL SURGEON AND THEY NOTED THERE WERE NO SIGNS OF OSTEOMYELITIS. THE WOUND WAS REOPENED AND THE OFFICE PERFORMED AN IRRIGATION AND DEBRIDEMENT. THE TREATING OFFICE INDICATED, THE PATIENT HAS NOT FOLLOWED UP WITH THE INFECTIOUS DISEASE SPECIALIST AND IS NOT TAKING THE

  Patient problems: Difficulty Chewing; Osteomyelitis; Swelling/ Edema

  MAUDE report 15577264 ↗