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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 K1076.5011
Medical Device Problem Code Use of Device Problem (1670)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 06/09/2025
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
MDR Report Key22435508
Report Number1060818-2025-00537
Device Sequence Number16934793
Product Code DZE
UDI-Device IdentifierE219K107650111
UDI-PublicE219K107650111
Combination Product (Y/N)N
Initial Reporter CountryIT
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2025
Device Explanted Year2025
Serviced by Third Party (Y/N)N
Reporter Type Importer
Report Source Company Representative
Initial Reporter Occupation Dentist
Type of Report Initial,Followup
Report Date (Section B) 07/31/2025
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 NumberK1076.5011
Device Catalogue NumberK1076.5011
Device Lot Number0020126380
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Supplement Date Received by ManufacturerNot provided
Initial Report FDA Received Date07/08/2025
Supplement Report FDA Received Date07/31/2025
Date Device Manufactured08/10/2022
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 Required Intervention;
Patient SexUnknown
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