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

Model Number	TLX4615
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed to osseointegrate.
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-0008 involving a review of complaints from 09/01/2025 to 12/31/2025.

• 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: 50460394
• Report Number: 1060818-2026-17352
• Device Sequence Number: 9898099
• Product Code: DZE
• UDI-Device Identifier: 00847236010126
• UDI-Public: 00847236010126
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K223697
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/26/2026

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: TLX4615
• Device Catalogue Number: TLX4615
• Device Lot Number: 2306845
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 08/26/2026
• Date Device Manufactured: 12/12/2023
• 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