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

Model Number	PGCMAV
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation determined: it appears that excessive force may have been applied to the abutment hex causing it to deform.2 of the 3 malfunction events did not have product returned for investigation.Therefore, no conclusion may be drawn to attribute to the reported fractured device.1 of the 3 malfunction events are under evaluation and no conclusion has been drawn.For any reported known and verified lot number, a review of the device history record took place.No nonconformance was noted.Therefore, the device was manufactured to specifications.
Event or Problem Description
This report is a summary of three (3) malfunction events.A review of the event(s) involved a device experiencing a broken hex or abutment.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: 16275255
• Report Number: 1060818-2022-18768
• Device Sequence Number: 14672723
• Product Code: NHA
• UDI-Device Identifier: 00847236021696
• UDI-Public: 00847236021696
• Combination Product (Y/N): N
• Number of Events Summarized: 3
• 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: PGCMAV
• Device Catalogue Number: PGCMAV
• 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