MAUDE Adverse Event Report: DATUM DENTAL LTD. OSSIX BONE 5*5*10 (0.25 CC); BONE GRAFTING MATERIAL, ANIMAL SOURCE

Catalog Number	OXB0250
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930)
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.The device was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.
Event or Problem Description
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.
Additional Manufacturer Narrative
Additional information received from us importer report # (b)(4) linked to this manufacturer report is included in the follow-up.

• 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: 22881528
• Report Number: 3027602316-2025-00003
• Device Sequence Number: 9313865
• Product Code: NPM
• UDI-Device Identifier: 07290015477222
• UDI-Public: 07290015477222
• Combination Product (Y/N): N
• PMA/510(K) Number: K163714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2026

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
• Device Catalogue Number: OXB0250
• Device Lot Number: OB25000362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/14/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/14/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/24/2025
• Supplement Report FDA Received Date: 09/23/2025; 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Female