MAUDE Adverse Event Report: BIOHORIZONS IMPLANT SYSTEMS BIOHORIZONS INTERNAL CUSTOM CAST ABUTMENT

Model Number	PGHYB
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
This report is a summary of eleven (11) malfunction events.A review of the event(s) involved a device experiencing a broken abutment or abutment hex.No adverse event patient information was reported.No information regarding patient demographics have been provided.

• Brand Name: BIOHORIZONS INTERNAL CUSTOM CAST ABUTMENT
• Common Device Name: INTERNAL CUSTOM CAST 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: 16859943
• Report Number: 1060818-2023-05272
• Device Sequence Number: 5717928
• Product Code: NHA
• UDI-Device Identifier: 00847236012106
• UDI-Public: 00847236012106
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• 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): 04/30/2023

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: PGHYB
• Device Catalogue Number: PGHYB
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown