MAUDE Adverse Event Report: ANTHOGYR AXIOM PX IMPLANT; IMPLANT AXIOM D. 4.0 X 18.0

Model Number	PX40180
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	09/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant fails to osseointegrate.

• Brand Name: AXIOM PX IMPLANT
• Common Device Name: IMPLANT AXIOM D. 4.0 X 18.0
• Manufacturer (Section D): ANTHOGYR; 2237 avenue andré lasquin; sallanches, ; FR
• MDR Report Key: 11383472
• Report Number: 8020776-2021-00352
• Device Sequence Number: 3545742
• Product Code: DZE
• UDI-Device Identifier: 03663394002615
• UDI-Public: 03663394002615
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K161177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 02/24/2021

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: 11/30/2022
• Device Model Number: PX40180
• Device Catalogue Number: PX40180
• Device Lot Number: 17-217456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 02/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1