MAUDE Adverse Event Report: Anthogyr AXIOM IMPLANT X3 ?3.4 x 14.0; Endosseous Dental Implant

Catalog Number	XT34140
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994); Fibrosis (3167); Hyperresponsive to stimuli (4538)
Date of Event	05/28/2026
Type of Reportable Event	Serious Injury

• Brand Name: AXIOM IMPLANT X3 ?3.4 x 14.0
• 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: 50653241
• Report Number: 0008020776-2026-000986
• Device Sequence Number: 13394091
• Product Code: DZE
• UDI-Device Identifier: 03663394483506
• UDI-Public: 03663394483506
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K230104
• 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): 09/07/2026

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: XT34140
• Device Lot Number: xcez5
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/13/2026
• 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: 09/07/2026
• Initial Report FDA Received Date: 09/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2026
• 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: 29 YR
• Patient Sex: Male