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

Model Number	PYCAH
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
1 of the 2 : the product was not returned for investigation.Therefore, no conclusion may be drawn to which caused the fracture.1 of the 2: the return includes what appears to be the bevel of an abutment.Neither the abutment body, abutment hex, nor abutment screw was returned for evaluation.It appears that the abutment bevel has been ground of the abutment body.The investigator was unable to confirm the identity of the returned part based on what was provided.No evaluation could be made based on the information provided.
Event or Problem Description
This report is a summary of two (2) 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.
Event or Problem Description
This report is a summary of two (2) 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.
Additional Manufacturer Narrative
1 of the 2 : the product was not returned for investigation.Therefore, no conclusion may be drawn to which caused the fracture.1 of the 2: the return includes what appears to be the bevel of an abutment.Neither the abutment body, abutment hex, nor abutment screw was returned for evaluation.It appears that the abutment bevel has been ground of the abutment body.The investigator was unable to confirm the identity of the returned part based on what was provided.No evaluation could be made based on the information 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: 16275269
• Report Number: 1060818-2022-18779
• Device Sequence Number: 20144173
• Product Code: NHA
• UDI-Device Identifier: 00847236005856
• UDI-Public: 00847236005856
• Combination Product (Y/N): N
• Number of Events Summarized: 2
• 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,Followup
• 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: PYCAH
• Device Catalogue Number: PYCAH
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 04/28/2023
• 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