MAUDE Adverse Event Report: DATUM DENTAL LTD. OSSIX BONE 5*10*10 (0.5 CC); BONE GRAFTING MATERIAL, ANIMAL SOURCE

Catalog Number	OXB0500
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.
Event or Problem Description
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.
Additional Manufacturer Narrative
Summary: the investigation into the reported lack of bone formation concludes that the root cause is use error, resulting from the clinician's admission to retaining and potentially reusing opened, single-use material in direct violation of the instructions for use (ifu).This practice compromises the sterility and efficacy of the graft, a risk likely exacerbated by the clinician's decision to prescribe only analgesics (novalgina) without antibiotic coverage.Batch record review ((b)(4)) confirmed the device was manufactured within all specifications and no similar complaint trends were identified, confirming the failure is isolated to clinical handling rather than a device defect.

• 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: 23356382
• Report Number: 3027602316-2025-00006
• Device Sequence Number: 8824100
• Product Code: NPM
• UDI-Device Identifier: 07290015477253
• UDI-Public: 07290015477253
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K163714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: OXB0500
• Device Lot Number: 0B50000408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/08/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 12/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown