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

Model Number	PGSEA
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The return includes the abutment without the crown intact, the fractured abutment hex, and the abutment screw.Deformation can be observed around the abutment bevel connection.Areas of green anodization has worn off from around the fractured hex.Significant deformation can be observed within the internal hex engagements of the abutment screw.The abutment screw appears to be stripped.
Event or Problem Description
This report is a summary of one (1) malfunction event.A review of the event(s) involved a device experiencing a broken hex.No adverse event patient information was reported.No information regarding patient demographics have been provided.

• Brand Name: BIOHORIZONS INTERNAL STRAIGHT ESTHETIC ABUTMENT
• Common Device Name: INTERNAL STRAIGHT 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
• Manufacturer Contact: anissa smith ; 2300 riverchase center; birmingham, AL 35244
• MDR Report Key: 16275263
• Report Number: 1060818-2022-18774
• Device Sequence Number: 4881077
• Product Code: NHA
• UDI-Device Identifier: 00847236005399
• UDI-Public: 00847236005399
• 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): 01/31/2023

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: PGSEA
• Device Catalogue Number: PGSEA
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2023
• 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