MAUDE Adverse Event Report: BIOHORIZONS IMPLANT SYSTEMS BIOHORIZONS CUSTOM MILLED ABUTMENT

Model Number	PGCMAV
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 summarizes eight (8) malfunction event.A review of the events involved the abutment fractured.No patient adverse events were reported.No information regarding patient demographics were provided.
Event or Problem Description
This report summarizes eight (8) malfunction event.A review of the events involved the abutment fractured.No patient adverse events were reported.No information regarding patient demographics were provided.

• Brand Name: BIOHORIZONS CUSTOM MILLED ABUTMENT
• Common Device Name: CUSTOM MILLED 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: 23413700
• Report Number: 1060818-2025-07337
• Device Sequence Number: 13363998
• Product Code: NHA
• UDI-Device Identifier: 00847236021696
• UDI-Public: 00847236021696
• Combination Product (Y/N): N
• PMA/510(K) Number: K151621
• Exemption Number: VMSR
• Number of Events Summarized: 8
• 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: PGCMAV
• Device Catalogue Number: PGCMAV
• 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