MAUDE Adverse Event Report: DATUM DENTAL LTD. OSSIX VOLUMAX; Barrier, animal source, intraoral

Model Number	OXV1525
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	Neuralgia (4413)
Type of Reportable Event	Serious Injury
Event or Problem Description
21-year-old healthy female had implants placed in the ur1 and ul 1 positions, without additional bone grafting.A 15x25mm volumax was used buccally to thicken soft tissues.Patient started to get a neuralgia type pain from the ul 1 implant (ur1 absolutely fine); the doctor had to re-enter at 1 month to remove the left implant.On re-entry, the volumax was found to be no longer as one intact piece - it was yellowish and soft like goo and had lost its dimensional stability.The doctor removed the volumax.
Additional Manufacturer Narrative
Failure to manage the material or relax the flap in this manner may lead to the formation of inflammation and or infection around this material.This could also lead to the description of a yellowish and soft presentation of volumax.

• Brand Name: OSSIX VOLUMAX
• Common Device Name: Barrier, animal source, intraoral
• 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: 18862943
• Report Number: 3010626093-2024-00001
• Device Sequence Number: 8238919
• Product Code: NPL
• UDI-Device Identifier: 07290015477123
• UDI-Public: 7290015477123
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K153549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 03/07/2024

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: 01/18/2026
• Device Model Number: OXV1525
• Device Lot Number: OV1500663
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 03/07/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL IMPLANT
• Outcome Attributed to Adverse Event: Other
• Patient Age: 21 YR
• Patient Sex: Female