MAUDE Adverse Event Report: ALTATEC ALTATEC; DENTAL IMPLANT

Model Number	P1410.3809
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed to osseointegrate.

• Brand Name: ALTATEC
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ALTATEC; maybachstrasse 5; wimsheim 71299 ; GM 71299
• MDR Report Key: 25380464
• Report Number: 1060818-2026-60377
• Device Sequence Number: 16094200
• Product Code: DZE
• UDI-Device Identifier: E219P141038091
• UDI-Public: E219P141038091
• 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: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 06/04/2026

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: P1410.3809
• Device Catalogue Number: P1410.3809
• Device Lot Number: 0080503742
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/05/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/03/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown