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

Model Number	OSSIX BONE 0.25 CC
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the clinic that ossix bone failure lead to implant loss.

• Brand Name: OSSIX BONE
• Common Device Name: BONE GRAFTING MATERIAL, ANIMAL SOURCE
• 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, 71201-01
• MDR Report Key: 14163915
• Report Number: 3010626093-2022-00001
• Device Sequence Number: 11915405
• Product Code: NPM
• UDI-Device Identifier: 07290015477222
• UDI-Public: 7290015477222
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K163714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 04/20/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/02/2023
• Device Model Number: OSSIX BONE 0.25 CC
• Device Lot Number: OB25000113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 04/20/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ASTRATECH EV IMPLANT
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown