MAUDE Adverse Event Report: BIOHORIZONS IMPLANT SYSTEMS BIOHORIZONS ABUTMENT SCREW; MULTI-UNIT ABUTMENT SCREW

Model Number	PXMUAS
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
This report provides a summary of one (1) malfunction event.A review of the event involved the reported abutment screw stripped during usage.No patient adverse event was reported.No information regarding patient demographics have been provided.
Additional Manufacturer Narrative
There was one malfunction event reported with the abutment screw stripping during usage.No physical evaluation was performed due to product not being returned.Because no product was returned for evaluation and no other details were provided, no conclusion can be drawn to the reported issue.Therefore, root cause was concluded unable to determine.(b)(4).

• Brand Name: BIOHORIZONS ABUTMENT SCREW
• Common Device Name: MULTI-UNIT ABUTMENT SCREW
• 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: 15705048
• Report Number: 1060818-2022-13576
• Device Sequence Number: 4972697
• Product Code: NHA
• UDI-Device Identifier: 00847236006532
• UDI-Public: 00847236006532
• 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: Dentist
• Type of Report: Initial
• Report Date (Section B): 10/31/2022

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: PXMUAS
• Device Catalogue Number: PXMUAS
• Device Lot Number: PO21030262
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2022
• 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