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

Model Number	TLR4615
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
System experienced an internal error in submission.The system provider salesforce trackwise was notified under support case (b)(4) to address.It was determined a new email address was needed that did not require a change in password.Trackwise support indicated anytime a password occurs with the associated email address an internal error will be received.To fix the issue, a new biohorizons forwarding email address that did not require a change in password at any time.The effort was performed to update the email address.It is believed this records were impacted why the change to email was being impacted.
Event or Problem Description
Implant failed to osseointegrate.
Event or Problem Description
Implant failed to osseointegrate.

• 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
• Manufacturer Contact: anissa smith ; 2300 riverchase center; birmingham
• MDR Report Key: 24392641
• Report Number: 1060818-2026-01747
• Device Sequence Number: 10518896
• Product Code: DZE
• UDI-Device Identifier: 00847236009939
• UDI-Public: 00847236009939
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 03/13/2026

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 Expiration Date: 06/28/2026
• Device Model Number: TLR4615
• Device Catalogue Number: TLR4615
• Device Lot Number: 2104310
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2021
• 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