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	02/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Biohorizons issue: record failed with reason of duplicate number.Honeywell sparta vendor response: more than one registered site using the registration number 1060818 was assigned the same number.Therefore, causing the records to have a duplicate.Various sites having same value in "assigned number" for two or more registered sites will create the duplicate report number using between the emdr with different registered sites, when on start of the year, last used sequence number will reset to 1 for all the registered site.Corrective action by biohorizons: updated the last used sequence number field value to 60000 for rs-0002 and with 80000 for rs-0003, as rs-0000, rs0002 and rs0003 share the same registration number.The vendor suggested as a workaround by creating a starting sequence range high enough to prevent duplication.For importer files, the sequence number begins at 60000 for 2026.Clear the duplicate mfr report number and resubmit the record to capture the new last sequence number beginning with 60nnnn.The clearance would be either through automation or manually.Preventative action: work with vendor honeywell/sparta to create an automation to update the last used sequence number in the future and prevent duplication records.
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: 25336984
• Report Number: 1060818-2026-60288
• Device Sequence Number: 9842940
• 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 Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 03/06/2026

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: 0070155541
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/04/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/29/2026
• 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