MAUDE Adverse Event Report: DATUM DENTAL LTD. OSSIX BONE 5*5*5 (0.125 CC); BONE GRAFTING MATERIAL, ANIMAL SOURCE

Catalog Number	OXB0125
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
While it is unknown if the device used in this case caused or contributed to the patient¿s symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material.Therefore, this event meets the criteria for reportability per 21 cfr part 803.
Event or Problem Description
It was reported that a patient experienced an allergic reaction during a dental procedure that included the use of ossix bone, dentsply articaine and amoxicillin.The patient ended up in emergency department.The doctor reported that the patient has had antibiotics before without issue.

• Common Device Name: BONE GRAFTING MATERIAL, ANIMAL SOURCE
• Manufacturer (Section D): DATUM DENTAL LTD.; 38 hayarkon st.; yavne central 81227 41; IS 8122741
• Manufacturer (Section G): DATUM DENTAL LTD.; 38 hayarkon st.; yavne central 81227 41; IS 8122741
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 21889706
• Report Number: 3027602316-2025-00001
• Device Sequence Number: 15478309
• Product Code: NPM
• UDI-Device Identifier: 07290015477215
• UDI-Public: 07290015477215
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K163714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 04/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: OXB0125
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/07/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female