MAUDE Adverse Event Report: BIOHORIZONS IMPLANT SYSTEMS BIOHORIZONS ABUTMENT; INTERNAL ABUTMENT

Model Number	PGREA
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes seven (7) malfunction event.A review of the events involved abutment breaking or being fractured.No patient adverse events were reported.No information regarding patient demographics were provided.

• Brand Name: BIOHORIZONS ABUTMENT
• Common Device Name: INTERNAL 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: 21937174
• Report Number: 1060818-2025-70014
• Device Sequence Number: 12113615
• Product Code: NHA
• UDI-Device Identifier: 00847236005313
• UDI-Public: 00847236005313
• Combination Product (Y/N): N
• PMA/510(K) Number: K223697
• Number of Events Summarized: 7
• 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
• Report Date (Section B): 04/30/2025

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: PGREA
• Device Catalogue Number: PGREA
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2025
• 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