MAUDE Adverse Event Report: BIOHORIZONS IMPLANT SYSTEMS BIOHORIZONS INTERNAL REGULAR EMERGENCE 3INONE ABUTMENT; INTERNAL 3.5 REGULAR EMERGENCE 3INONE ABUTMENT

Model Number	PYREA
Medical Device Problem Code	Fracture (1260)
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) has a fractured abutment.No patient adverse event was reported.No information regarding patient demographics were provided.

• Brand Name: BIOHORIZONS INTERNAL REGULAR EMERGENCE 3INONE ABUTMENT
• Common Device Name: INTERNAL 3.5 REGULAR EMERGENCE 3INONE 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: 21937166
• Report Number: 1060818-2025-70005
• Device Sequence Number: 5404709
• Product Code: NHA
• UDI-Device Identifier: 00847236006112
• UDI-Public: 00847236006112
• Combination Product (Y/N): N
• PMA/510(K) Number: K223697
• 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
• 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: PYREA
• Device Catalogue Number: PYREA
• 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