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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANTHOGYR AXIOM PX IMPLANT; IMPLANT AXIOM D. 4.0 X 18.0
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ANTHOGYR AXIOM PX IMPLANT; IMPLANT AXIOM D. 4.0 X 18.0 Back to Search Results
Model Number PX40180
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 07/17/2017
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 11 position on (b)(6) 2016 and removed on (b)(6) 2017.
 
Event or Problem Description
Implant is lost (loss of osseointegration) after implant has been restored.
 
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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 Key7167802
Report Number8020776-2018-00011
Device Sequence Number1827070
Product Code DZE
UDI-Device Identifier03663394002615
UDI-Public03663394002615
Combination Product (Y/N)N
Initial Reporter CountryPO
PMA/510(K) Number
K161177
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2017
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 01/05/2018
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 Date10/03/2019
Device Model NumberPX40180
Device Catalogue NumberPX40180
Device Lot Number14-028751
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2017
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/07/2017
Initial Report FDA Received Date01/05/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age60 YR
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