OSSIX™ Bone 0.250 ccRecalls & reported problems

Datum Dental Ltd · OSSIX™ BONE is a biodegradable, osteoconductive, and biocompatible bone grafting material intended for guided tissue and bone regeneration. The OSSIX™ BONE matrix is composed of 80% synthetic crystalline non-sintered hydroxylapatite and 20% collagen, which is derived from veterinary certified pigs and is purified and cross-linked. · Class 2 · Implant

Adverse event reports: 5
Deaths reported: 0
Injuries reported: 4
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07290015477222), received between Apr 20, 2022 and Jul 30, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Osseointegrate” (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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Failure to Osseointegrate2
Patient-Device Incompatibility2
Adverse Event Without Identified Device or Use Problem1

Patient problems

Hypersensitivity/Allergic reaction3
Unspecified Infection3
Cellulitis1
Discomfort1
Failure of Implant1
Implant Pain1
Inadequate Osseointegration1
Inflammation1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

InjuryJul 30, 2026Failure to Osseointegrate
A doctor used the OSSIX Bone which resulted in an adverse reaction as follow:"Adverse reaction. Infected extraction site. They used OSSIX Bone and PTF nonresorbable membrane (not sure if that is ours or not), and nonresorbable suture. The patient has pain and is itchy. May have used a CBD product for pain."
Patient problems: Discomfort; Hypersensitivity/Allergic reaction; Inadequate Osseointegration; Pain; Unspecified Infection
MAUDE report 50087029 ↗
InjuryAug 24, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT OSSIX BONE 5*5*10 (0.25 CC) ALLEGEDLY CAUSED LOT OF PAIN, SWELLING AND TISSUE INFECTION. THE PATIENT HAS BEEN SEEN SINCE, THEY ARE IN A LOT OF PAIN AND HAD TO HAVE SOME OF THE GRAFT AND TISSUE REMOVED. THE PATIENT WAS PLACED ON ANTIBIOTICS.
Patient problems: Hypersensitivity/Allergic reaction; Unspecified Infection
MAUDE report 22881528 ↗
InjuryAug 24, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT OSSIX BONE 5*5*10 (0.25 CC) ALLEGEDLY CAUSED LOT OF PAIN, SWELLING AND TISSUE INFECTION. THE PATIENT HAS BEEN SEEN SINCE; THEY ARE IN A LOT OF PAIN AND HAD TO HAVE SOME OF THE GRAFT AND TISSUE REMOVED. THE PATIENT WAS PLACED ON ANTIBIOTICS.
Patient problems: Hypersensitivity/Allergic reaction; Unspecified Infection
MAUDE report 22881500 ↗
InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HAD 10/10 PAIN, INFLAMMATION AND CELLULITIS. PATIENT COMPLAINED OF PAIN WITHIN 1 DAY OF PLACEMENT. PRODUCT WAS REMOVED.
Patient problems: Cellulitis; Implant Pain; Inflammation
MAUDE report 19567714 ↗
MalfunctionApr 20, 2022Failure to Osseointegrate
IT WAS REPORTED BY THE CLINIC THAT OSSIX BONE FAILURE LEAD TO IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 14163915 ↗

Device details

UDI-DI	`07290015477222`
Brand	OSSIX™ Bone
Model	0.250 cc
Catalog no.	OXB0250
Company	Datum Dental Ltd
Product code	NPM · Bone Grafting Material, Animal Source
Class	Class 2
FDA submission	K163714
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 9, 2026

Device type (GMDN): Dental bone matrix implant, synthetic

A sterile bioabsorbable device made of synthetic material implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is typically made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), sometimes bioactive glasses or bioabsorbable polymers, and used to fill bone cavities and defects to promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. It is typically provided as sterile cancellous blocks, chips, or granules of varying sizes, or mouldable materials.

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All Bone Grafting Material, Animal Source devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.