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

Model Number	PYMU2
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 a reported abutment stripping 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 stripping during usage.The evaluation revealed the abutment function as designed.However, the included abutment screw component had been manipulated causing damage to the abutment screw which connects the abutment to the implant.The abutment screw manipulation contributed to the reported allegation of a stripped abutment.The abutment itself was not stripped but a component of the abutment was manipulated.A review of the device history did not note any nonconformance issues during manufacturing.Therefore, the actual abutment function as designed if paired with a abutment screw that has not been manipulated.(b)(4).

• Brand Name: BIOHORIZONS MULTI-UNIT ABUTMENT
• Common Device Name: MULTI-UNIT 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: 15704367
• Report Number: 1060818-2022-13575
• Device Sequence Number: 6584387
• Product Code: NHA
• UDI-Device Identifier: 00847236006730
• UDI-Public: 00847236006730
• 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: PYMU2
• Device Catalogue Number: PYMU2
• Device Lot Number: 2202275
• 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): Yes
• 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