MAUDE Adverse Event Report: ANTHOGYR AXIOM REG IMPLANT; IMPLANT AXIOM D. 3.4 X 16.0

Model Number	OP34160
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	11/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Our experience with early losses suggests that the source of the problem is likely to stem from procedural errors (e.G.Patient evaluation and compliance), and/or post-operative complications like inflammation (lack of osseointegration) or loading through the temporary prosthesis/pressure of the tongue.Also, we have evaluated this event and concluded that the loss of integration or the non-integration of the endosseous dental implant is a known inherent risk of the procedure.We have evaluated this event and can confirm that the failure to integrate of endosseous dental implants is a known inherent risk of the procedure.Our trend analysis confirms that the reported failure rate associated with our implants is below the expected failure rate for this procedure as published in the scientific literature.Therefore no corrective and/or preventive measures were taken.
Event or Problem Description
Implant fails to osseointegrate.

• Brand Name: AXIOM REG IMPLANT
• Common Device Name: IMPLANT AXIOM D. 3.4 X 16.0
• Manufacturer (Section D): ANTHOGYR; 2237 avenue andré lasquin; sallanches, 74700 ; FR 74700
• MDR Report Key: 9925934
• Report Number: 8020776-2020-00686
• Device Sequence Number: 16968223
• Product Code: DZE
• UDI-Device Identifier: 03663394000093
• UDI-Public: 03663394000093
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K101913
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 03/25/2020

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: No Information
• Device Expiration Date: 07/17/2023
• Device Model Number: OP34160
• Device Lot Number: 18-267198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 04/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR