MAUDE Adverse Event Report: BIOHORIZONS IMPLANT SYSTEMS BIOHORIZONS MULTI-UNIT ABUTMENT; STRAIGHT MULTI-UNIT ABUTMENT

Model Number	TP3MU2
Medical Device Problem Codes	Fracture (1260); Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
This report indicates two (2) malfunction event.A review of the event involved of the device(s) being fractured.No patient adverse event was reported.No information regarding patient demographics were provided.
Event or Problem Description
This report indicates two (2) malfunction event.A review of the event involved of the device(s) being fractured.No patient adverse event was reported.No information regarding patient demographics were provided.

• Brand Name: BIOHORIZONS MULTI-UNIT ABUTMENT
• Common Device Name: STRAIGHT MULTI-UNIT ABUTMENT
• Manufacturer (Section D): BIOHORIZONS IMPLANT SYSTEMS; 2300 riverchase center; birmingham AL 35244
• Manufacturer (Section G): BIOHORIZONS IMPLANT SYSTEMS; 2300 riverchase center; birmingham AL 35244
• MDR Report Key: 23413675
• Report Number: 1060818-2025-07325
• Device Sequence Number: 13007669
• Product Code: NHA
• UDI-Device Identifier: 00847236006839
• UDI-Public: 00847236006839
• Combination Product (Y/N): N
• PMA/510(K) Number: K223697
• Exemption Number: VMSR
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TP3MU2
• Device Catalogue Number: TP3MU2
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 02/10/2026
• 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
• Patient Sex: Unknown