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	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Discomfort (2330); Inadequate Osseointegration (2646)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.Section h6 was done based on the information provided by the reporter and our experience in the investigation of complaints.The product return is requested and it will be evaluated after receipt.Additional information has been requested.Should additional information become available, a follow-up report will be submitted.Trend is tracked and monitored.
Event or Problem Description
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.".

• 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 ; +1(717)845-7511
• MDR Report Key: 50087029
• Report Number: 3027602316-2026-00032
• Device Sequence Number: 21332619
• Product Code: NPM
• UDI-Device Identifier: 07290015477222
• UDI-Public: 07290015477222
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K163714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 07/30/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: OXB0250
• Device Lot Number: OB50000418
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown