MAUDE Adverse Event Report: ALTATEC ALTATEC; DENTAL IMPLANT

Model Number	C1086.4309
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The initial emdr record was due for submission on (b)(6) 2026.Due to a high volume of complaint entries, the complaint assessment was completed later than expected, which delayed creation of the emdr submission record.Following completion of the reportability assessment, the emdr record was created on (b)(6) 2026.The importance of timely complaint entry and direct correlation to the creation of other complaint records has been reviewed with the team.
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; maybachstrasse 5; wimsheim 71299 ; GM 71299
• MDR Report Key: 25546885
• Report Number: 1060818-2026-60466
• Device Sequence Number: 21519223
• Product Code: DZE
• UDI-Device Identifier: E219C108643091
• UDI-Public: E219C108643091
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 06/13/2026

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: C1086.4309
• Device Catalogue Number: C1086.4309
• Device Lot Number: 0010419166
• 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
• Initial Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2025
• 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