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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELEMENT MC INICELL, PF 6.0, E 6.0, L8.0; DENTAL IMPLANT
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ELEMENT MC INICELL, PF 6.0, E 6.0, L8.0; DENTAL IMPLANT Back to Search Results
Model Number 4.23.552
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 06/24/2021
Type of Reportable Event Serious Injury
Event or Problem Description
Loss of osseointegration, implant achieved osseointegration, primary stability was achieved, implant was completely covered with bone, no thread tap used, infection, mobility.
 
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Brand Name
ELEMENT MC INICELL, PF 6.0, E 6.0, L8.0
Common Device Name
DENTAL IMPLANT
MDR Report Key12702587
Report Number3003184527-2021-01497
Device Sequence Number19222130
Product Code DZE
UDI-Device Identifier07640156470031
UDI-Public07640156470031
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K093615
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2021
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 10/22/2021
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 Health Professional
Device Expiration Date04/30/2020
Device Model Number4.23.552
Device Lot Number12201
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/22/2021
Initial Report FDA Received Date10/27/2021
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured04/30/2015
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age77 YR
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