MAUDE Adverse Event Report: ANTHOGYR AXIOM IMPLANT X3 Ø6.4 X 8.0; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	XT64080
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports that the day the implant was placed in fdi 17, failure occurred upon insertion.Details of surgery: immediate extraction site.Patient presented with inadequate bone quality/quantity.The device was forwarded to the manufacturer.There were no reported patient injuries or complications.
Additional Manufacturer Narrative
The batch number could not be verified due to incomplete or missing information and / or product from the customer.Our manufacturing q-system assures that production and process controls are in place to ensure that batches confirm to the applicable specifications before they are distributed.The removal of a dental implant during surgery without the replacement of another dental implant is a known inherent risk of the procedure due to either lack of primary stability of the implant (patient or procedure related).It may also include the removal of an implant after osseointegration due to either the clinician's or patient¿s decision.The manufacturer¿s trend analysis confirms that usually procedural errors and/or patient's condition contribute to the event.

• Brand Name: AXIOM IMPLANT X3 Ø6.4 X 8.0
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): ANTHOGYR; 2237, avenue andré-lasquin; sallanches 74700 ; FR 74700
• Manufacturer (Section G): ANTHOGYR; 2237, avenue andré-lasquin; sallanches 74700 ; FR 74700
• Manufacturer Contact: jennifer jackson ; 60 minuteman road; andover, MA 01810 ; 9787472509
• MDR Report Key: 21140842
• Report Number: 0008020776-2025-000024
• Device Sequence Number: 12658127
• Product Code: DZE
• UDI-Device Identifier: 03663394483759
• UDI-Public: 03663394483759
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K230104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 01/13/2025

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: XT64080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/13/2025
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Male