MAUDE Adverse Event Report: BioHorizons Implant Systems BioHorizons Custom Milled Abutment

Model Number	PYCMAV
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction

• 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: 50098570
• Report Number: 1060818-2026-25547
• Device Sequence Number: 13330020
• Product Code: NHA
• UDI-Device Identifier: 00847236021702
• UDI-Public: 00847236021702
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151621
• Exemption Number: VMSR
• Number of Events Summarized: 12
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 07/31/2026

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: PYCMAV
• Device Catalogue Number: PYCMAV
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/31/2026
• 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