MAUDE Adverse Event Report: Anthogyr AXIOM IMPLANT ?3.4 x 8.0; Endosseous Dental Implant

Catalog Number	OP34080
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Fibrosis (3167)
Date of Event	05/23/2026
Type of Reportable Event	Serious Injury

• Brand Name: AXIOM IMPLANT ?3.4 x 8.0
• Common Device Name: Endosseous Dental Implant
• Manufacturer (Section D): Anthogyr; 2237, avenue andr?-lasquin; sallanches 74700 ; FR 74700
• Manufacturer (Section G): Anthogyr; 2237, avenue andr?-lasquin; sallanches 74700 ; FR 74700
• Manufacturer Contact: jennifer jackson ; 60 minuteman road; andover, MA 01810 ; +1(978)747-2509
• MDR Report Key: 50413974
• Report Number: 0008020776-2026-000937
• Device Sequence Number: 9172744
• Product Code: DZE
• UDI-Device Identifier: 03663394000055
• UDI-Public: 03663394000055
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K101913
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 08/24/2026

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: OP34080
• Device Lot Number: CGGR4
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/30/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2023
• 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 Age: 46 YR
• Patient Sex: Male