MAUDE Adverse Event Report: BIOHORIZONS INC BIOHORIZONS INC; DENTAL IMPLANT

Model Number	TRX3812
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed to osseointegrate.

• Brand Name: BIOHORIZONS INC
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOHORIZONS INC; 2300 riverchase ctr; birmingham AL 35244
• Manufacturer Contact: anissa smith
• MDR Report Key: 23631920
• Report Number: 1060818-2025-36438
• Device Sequence Number: 10314357
• Product Code: DZE
• UDI-Device Identifier: 00847236020804
• UDI-Public: 00847236020804
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 11/23/2025

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 Expiration Date: 10/30/2023
• Device Model Number: TRX3812
• Device Catalogue Number: TRX3812
• Device Lot Number: 1806437
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 11/24/2025
• Date Device Manufactured: 10/31/2018
• 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