MAUDE Adverse Event Report: ANTHOGYR AXIOM REG IMPLANT; IMPLANT AXIOM D. 4.6 X 8.0

Model Number	OP46080
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	02/07/2017
Type of Reportable Event	Malfunction
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 36 position on 08-03-2016 and removed on (b)(6) 2017.
Event or Problem Description
Implant is lost (loss of osseointegration) after implant has been restored.

• Brand Name: AXIOM REG IMPLANT
• Common Device Name: IMPLANT AXIOM D. 4.6 X 8.0
• Manufacturer (Section D): ANTHOGYR; 2237 avenue andré lasquin; sallanches, 74700 ; FR 74700
• MDR Report Key: 6607491
• Report Number: 8020776-2017-00351
• Device Sequence Number: 10854978
• Product Code: DZE
• UDI-Device Identifier: 03663394000291
• UDI-Public: 03663394000291
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K101913
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Dentist
• Device Expiration Date: 11/18/2018
• Device Model Number: OP46080
• Device Lot Number: 13-002820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2017
• Initial Report FDA Received Date: 06/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR