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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELEMENT MC INICELL, PF 3.5, E 3.5, L14.0; DENTAL IMPLANT
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ELEMENT MC INICELL, PF 3.5, E 3.5, L14.0; DENTAL IMPLANT Back to Search Results
Model Number 4.23.516
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 09/17/2021
Type of Reportable Event Serious Injury
Event or Problem Description
Implant didn't achieve osseointegration, primary stability was achieved, implant wasn't completely covered with bone, no thread tap used, immediate implantation, peri-implantitis, mobility.
 
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Brand Name
ELEMENT MC INICELL, PF 3.5, E 3.5, L14.0
Common Device Name
DENTAL IMPLANT
MDR Report Key12725233
Report Number3003184527-2021-01524
Device Sequence Number5723339
Product Code DZE
UDI-Device Identifier07640156470260
UDI-Public07640156470260
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K093615
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
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 Date06/14/2023
Device Model Number4.23.516
Device Lot Number18032
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 Date10/30/2021
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured06/14/2018
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 Age47 YR
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