MAUDE Adverse Event Report: BioHorizons Inc. BioHorizons Inc.; Dental Implant

Model Number	TRX4609
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed to osseointegrate.
Additional Manufacturer Narrative
This report is being submitted as part of a remediation / retrospective review per capa-0029 involving a review of complaints from (b)(6) 2024 to (b)(6) 2026.

• Brand Name: BioHorizons Inc.
• Common Device Name: Dental Implant
• Manufacturer (Section D): BioHorizons Inc.; 2300 riverchase center; birmingham AL 35244
• Manufacturer (Section G): BioHorizons Inc.; 2300 riverchase center; birmingham AL 35244
• Manufacturer Contact: anissa smith ; 2300 riverchase center; birmingham, AL 35244
• MDR Report Key: 50946344
• Report Number: 1060818-2026-19816
• Device Sequence Number: 10446632
• Product Code: DZE
• UDI-Device Identifier: 00847236000554
• UDI-Public: 00847236000554
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K223697
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: TRX4609
• Device Catalogue Number: TRX4609
• Device Lot Number: 2305988
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 10/25/2023
• 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