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

Model Number	PYCAH
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
This is a summary report for five (5) malfunction event(s).A review of the event involved the abutment fractured.The report was received with no patient adverse event(s) being 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
• Manufacturer Contact: anissa smith ; 2300 riverchase center; birmingham, AL 35244
• MDR Report Key: 17431578
• Report Number: 1060818-2023-09805
• Device Sequence Number: 8885216
• Product Code: NHA
• UDI-Device Identifier: 00847236005856
• UDI-Public: 00847236005856
• Combination Product (Y/N): N
• Number of Events Summarized: 5
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial

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
• Device Model Number: PYCAH
• Device Catalogue Number: PYCAH
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown