MAUDE Adverse Event Report: DATUM DENTAL LTD. OSSIX BONE; BONE GRAFTING MATERIAL

Model Number	OXB0250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cellulitis (1768); Inflammation (1932); Implant Pain (4561)
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had 10/10 pain, inflammation and cellulitis.Patient complained of pain within 1 day of placement.Product was removed.

• Brand Name: OSSIX BONE
• Common Device Name: BONE GRAFTING MATERIAL
• Manufacturer (Section D): DATUM DENTAL LTD.; 1, bat sheva st.; lod, 71201 01; IS 7120101
• Manufacturer (Section G): DATUM DENTAL LTD.; 1, bat sheva st.; lod, 71201 01; IS 7120101
• Manufacturer Contact: 1, bat sheva st.; lod 71201
• MDR Report Key: 19567714
• Report Number: 3010626093-2024-00004
• Device Sequence Number: 14493193
• Product Code: NPM
• UDI-Device Identifier: 07290015477222
• UDI-Public: 7290015477222
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K163714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 06/19/2024

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 Expiration Date: 09/08/2025
• Device Model Number: OXB0250
• Device Lot Number: OB25000319
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 06/19/2024
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown