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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 K1046.6009
Medical Device Problem Code Use of Device Problem (1670)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 04/08/2026
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Record was discovered during the review of assigned task for submitting.The record required maintenance for submission.After the maintenance was performed, the record was not then submitted as expected.
 
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 Key25160330
Report Number1060818-2026-60195
Device Sequence Number10695012
Product Code DZE
UDI-Device IdentifierE219K104660091
UDI-PublicE219K104660091
Combination Product (Y/N)N
Initial Reporter StateLA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2026
Device Explanted Year2026
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 05/08/2026
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 NumberK1046.6009
Device Catalogue NumberK1046.6009
Device Lot Number0020420744
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date04/08/2026
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date05/13/2026
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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