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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 K1053.3809
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 02/27/2026
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This record was discovered during the monitoring of the system.Records were unable to be transmitted due to a system issue with vendor.Vendor system failed to connect to the fda gateway timely and advised not to transmit until fixed.The issue was fixed and addressed.However, the assigned processor failed to transmit via the gateway when instructed.
 
Event or Problem Description
Implant failed to osseointegrate.
 
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Brand Name
ALTATEC
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
ALTATEC
maybachstrasse 5
wimsheim 71299
GM  71299
MDR Report Key25209776
Report Number1060818-2026-60216
Device Sequence Number16093245
Product Code DZE
UDI-Device IdentifierE219K105338091
UDI-PublicE219K105338091
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2025
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 03/29/2026
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 NumberK1053.3809
Device Catalogue NumberK1053.3809
Device Lot Number0020037544
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date02/27/2026
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date05/18/2026
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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