MAUDE Adverse Event Report: ALTATEC GMBH ALTATEC; DENTAL IMPLANT

Model Number	C1065.3309
Medical Device Problem Codes	Use of Device Problem (1670); Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant removed due to surgical consideration within 36 hours.

• Brand Name: ALTATEC
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ALTATEC GMBH; maybachstrasse 5; wimsheim 71299 ; GM 71299
• MDR Report Key: 23693619
• Report Number: 1060818-2025-00967
• Device Sequence Number: 18735713
• Product Code: DZE
• UDI-Device Identifier: E219C106533091
• UDI-Public: E219C106533091
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 12/14/2025

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: C1065.3309
• Device Catalogue Number: C1065.3309
• Device Lot Number: 0020134944
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/14/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/02/2025
• Date Device Manufactured: 06/01/2023
• 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