MAUDE Adverse Event Report: BIOHORIZONS IMPLANT SYSTEMS BIOHORIZONS MULTI-UNIT ABUTMENT SCREW; MULTI-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
Additional Manufacturer Narrative
This report is a summary of one malfunction event.The report device was evaluated and determined surface irregularities can be observed around the abutment body.It appears during usage the abutment internal threads have been crossed threaded.The evaluation concluded the failure was caused by improper technique or improper use of product.The root cause was determined to be use error.Item number pxmuas (udi: (b)(4)).
Event or Problem Description
This report summarize one (1) malfunction event.A review of the event involved an abutment unable to insert into implant.Zero (0) patient adverse events were reported.No information regarding patient demographics have been provided.

• Brand Name: BIOHORIZONS MULTI-UNIT ABUTMENT SCREW
• Common Device Name: MULTI-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: 15705055
• Report Number: 1060818-2022-13572
• Device Sequence Number: 4972700
• 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: C3459
• 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