MAUDE Adverse Event Report: ALTATEC ALTATEC; DENTAL IMPLANT

Model Number	K1076.4311
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed to osseointegrate.
Event or Problem Description
Implant failed to osseointegrate.
Additional Manufacturer Narrative
Uf/importer report # 1060818-2026-60183-00 is an importer emdr report.Therefore, sections g and h were populated in error.Only section f of the report is required.This supplement emdr report is a correction report for uf/importer report # 1060818-2026-60183-00 to be an importer emdr report only.

• Brand Name: ALTATEC
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ALTATEC; maybachstrasse 5; wimsheim 71299 ; GM 71299
• MDR Report Key: 25159653
• Report Number: 1060818-2026-60183
• Device Sequence Number: 9316247
• Product Code: DZE
• UDI-Device Identifier: E219K107643111
• UDI-Public: E219K107643111
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Report Source: Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2026

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 Number: K1076.4311
• Device Catalogue Number: K1076.4311
• Device Lot Number: 0030152326
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 05/14/2026
• Date Device Manufactured: 07/03/2024
• 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 Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown