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

Model Number	TRXP3810
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed to osseointegrate.
Additional Manufacturer Narrative
The delay in submission was due to a system issue involving the generation of duplicate report numbers.The vendor, (b)(4) was notified after several emdr records failed to submit.At the vendor¿s request, submission of similar records was temporarily halted while the root cause was investigated and a corrective solution was developed.Prior to identification of the system issue, the affected records were on track for timely submission.Due to the time required for vendor investigation, root cause analysis, and implementation of a corrective action, the records subsequently became past due.The corrective fix has now been deployed within the system.Newly created records are functioning as expected, and the vendor is actively monitoring system performance as a precaution.
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 AL 35244
• Manufacturer Contact: anissa smith ; 2300 riverchase center; birmingham, AL 35244
• MDR Report Key: 25152447
• Report Number: 1060818-2026-08966
• Device Sequence Number: 9351929
• Product Code: DZE
• UDI-Device Identifier: 00847236012700
• UDI-Public: 00847236012700
• 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): 05/12/2026

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: TRXP3810
• Device Catalogue Number: TRXP3810
• Device Lot Number: 2207132
• 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: 03/02/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 05/12/2026
• Supplement Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2022
• 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