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

Model Number	PXMUPSS
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 and a fractured prosthetic screw with the thread portion of the screw retained within the abutment.Deformation can be observed around the abutment hex.Deformation can also be seen within the internal hex engagements of the fractured prosthetic screw.
Event or Problem Description
This report is a summary of one (1) 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 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
• Manufacturer Contact: anissa smith ; 2300 riverchase center; birmingham, AL 35244
• MDR Report Key: 16275267
• Report Number: 1060818-2022-18778
• Device Sequence Number: 11982155
• Product Code: NHA
• UDI-Device Identifier: 00847236014124
• UDI-Public: 00847236014124
• 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: PXMUPSS
• Device Catalogue Number: PXMUPSS
• 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