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

Model Number	TMR4612
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed to osseointegrate.
Additional Manufacturer Narrative
The initial emdr record was due for submission on april 26, 2026.However, the associated reportability assessment¿the controlling record for to create the submission record¿was not completed by the processor until (b)(6) 2026.As a result, the delayed completion of the reportability assessment record directly contributed to the late submission of the emdr.

• 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: 25228352
• Report Number: 1060818-2026-09517
• Device Sequence Number: 5239339
• Product Code: DZE
• UDI-Device Identifier: 00847236010331
• UDI-Public: 00847236010331
• 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,Followup
• Report Date (Section B): 08/31/2026

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: TMR4612
• Device Catalogue Number: TMR4612
• Device Lot Number: 2404877
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 05/20/2026
• Supplement Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2024
• 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