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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 P1410.3811
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 12/17/2025
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Record was skipped accidently during the transmission of over 100 records.The transmission of records is a manual process within the system.This record was discovered during the monthly review of complaints.The record also required corrections and maintenance to the correct fields being populated.Therefore, causing the record to be transmitted late.
 
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 Key25383076
Report Number1060818-2026-60407
Device Sequence Number13058379
Product Code DZE
UDI-Device IdentifierE219P141038111
UDI-PublicE219P141038111
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
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 01/16/2026
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 NumberP1410.3811
Device Catalogue NumberP1410.3811
Device Lot Number0070149425
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/03/2026
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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