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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALTATEC ALTATEC; DENTAL IMPLANT
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ALTATEC ALTATEC; DENTAL IMPLANT Back to Search Results
Model Number C1065.3807
Medical Device Problem Code Use of Device Problem (1670)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 02/14/2025
Type of Reportable Event Serious Injury
Event or Problem Description
Implant removed due to surgical consideration within 36 hours.
 
Event or Problem Description
Implant removed due to surgical consideration within 36 hours.
 
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Brand Name
ALTATEC
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
ALTATEC
maybachstrasse 5
wimsheim 71299
GM  71299
Manufacturer Contact
anissa smith
MDR Report Key21540504
Report Number1060818-2025-00225
Device Sequence Number17925748
Product Code DZE
UDI-Device IdentifierE219C106538071
UDI-PublicE219C106538071
Combination Product (Y/N)N
Initial Reporter StateLA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2024
Device Explanted Year2024
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Dentist
Type of Report Initial,Followup
Report Date (Section B) 04/11/2025
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 Model NumberC1065.3807
Device Catalogue NumberC1065.3807
Device Lot Number0020133430
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date02/14/2025
Initial Date Received by Manufacturer Not provided
Supplement Date Received by ManufacturerNot provided
Initial Report FDA Received Date03/06/2025
Supplement Report FDA Received Date05/08/2025
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device A
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient SexUnknown
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