Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALTATEC ALTATEC; DENTAL IMPLANT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ALTATEC ALTATEC; DENTAL IMPLANT Back to Search Results
Model Number HP1040.3813
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ALTATEC
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
ALTATEC
maybachstrasse 5
wimsheim 71299
GM  71299
MDR Report Key25149794
Report Number1060818-2026-60149
Device Sequence Number9333651
Product Code DZE
UDI-Device Identifier00847236012700
UDI-Public00847236012700
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2025
Device Explanted Year2026
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
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 NumberHP1040.3813
Device Catalogue NumberHP1040.3813
Device Lot Number4067751
Is the Reporter a Health Professional? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/09/2026
Initial Report FDA Received Date05/12/2026
Date Device Manufactured06/05/2024
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
-
-