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

Model Number	PX40180
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	12/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the practitioner the implant is lost (loss of osseointegration) after implant has been restored.The implant has been placed in 15 position on (b)(6) 2018 and removed on (b)(6) 2018.The implant has followed the complete manufacturing cycle, has been verified at each stage of production, and has been submitted to a final release before provision of the device on the market, which ultimately guarantees its conformity.The implant has been evaluated through a biological risk assessment which concludes that its toxicological profile is acceptable.The implant loss suggests that the source of the problem was likely to come from procedural errors and/or the lack of osseointegration.Additionally, other factors that may have contributed to the implant failure include bone condition, patient oral hygiene, or patient behavior.
Event or Problem Description
Implant is lost (loss of osseointegration) after implant has been restored.

• 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, 74700 ; FR 74700
• MDR Report Key: 8269864
• Report Number: 8020776-2019-00048
• Device Sequence Number: 141670
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 01/18/2019

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: 05/05/2022
• Device Model Number: PX40180
• Device Catalogue Number: PX40180
• Device Lot Number: 17-175003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2019
• Initial Report FDA Received Date: 01/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR