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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, L11.0; DENTAL IMPLANT
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ELEMENT MC INICELL, PF 6.0, E 6.0, L11.0; DENTAL IMPLANT Back to Search Results
Model Number 4.23.554
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 09/29/2021
Type of Reportable Event Serious Injury
Event or Problem Description
Primary stability not achieved, implant was completely covered with bone, no thread tap used - implant was placed right after explantation of an older implant - implant diameter was too big.
 
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Brand Name
ELEMENT MC INICELL, PF 6.0, E 6.0, L11.0
Common Device Name
DENTAL IMPLANT
MDR Report Key12725534
Report Number3003184527-2021-01532
Device Sequence Number4446603
Product Code DZE
UDI-Device Identifier07640156470017
UDI-Public07640156470017
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) 10/05/2021
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 Date03/05/2024
Device Model Number4.23.554
Device Lot Number19621
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 10/05/2021
Initial Report FDA Received Date10/31/2021
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured03/05/2019
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 Age67 YR
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