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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 C1085.5009
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 03/09/2026
Type of Reportable Event Serious Injury
Event or Problem Description
Implant failed to osseointegrate.
 
Additional Manufacturer Narrative
The record was located during database review.This submission was an oversight by the processor during the submission of a heavy submission processing day.
 
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Brand Name
ALTATEC
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
ALTATEC
maybachstrasse 5
wimsheim 71299
GM  71299
MDR Report Key25149750
Report Number1060818-2026-60148
Device Sequence Number10750188
Product Code DZE
UDI-Device Identifier00847236012700
UDI-Public00847236012700
Combination Product (Y/N)N
Initial Reporter StateIL
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
Report Source Company Representative
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 04/08/2026
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 NumberC1085.5009
Device Catalogue NumberC1085.5009
Device Lot Number0030157660
Is the Reporter a Health Professional? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date05/12/2026
Date Device Manufactured11/29/2024
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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