MAUDE Adverse Event Report: DATUM DENTAL LTD. OSSIX VOLUMAX; RESORBABLE COLLAGEN MEMBRANE

Model Number	OXV1525
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Unspecified Infection (1930); Osteolysis (2377)
Date of Event	12/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced a dental implant loss following severe swelling, infection and osteolysis where ossix volumax was placed.

• Brand Name: OSSIX VOLUMAX
• Common Device Name: RESORBABLE COLLAGEN MEMBRANE
• Manufacturer (Section D): DATUM DENTAL LTD.; 1 bat sheva st.; lod, 71201 0; IS 712010
• 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: 16359088
• Report Number: 3010626093-2023-00001
• Device Sequence Number: 6220874
• Product Code: NPL
• UDI-Device Identifier: 07290015477123
• UDI-Public: 7290015477123
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K153549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 02/10/2023

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: 04/20/2025
• Device Model Number: OXV1525
• Device Lot Number: OV1500530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: PRIME TAPER EV 03.6 X 11 MM OS
• Outcome Attributed to Adverse Event: Other
• Patient Age: 39 YR
• Patient Sex: Male