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

Model Number	PYCMA
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
This report provides a summary for one (1) malfunction event connected to a reported abutment unable to seat properly at the time of usage.No patient adverse event was reported.No information regarding patient demographics have been provided.
Additional Manufacturer Narrative
This report provides a summary for one (1) malfunction event connected to a reported abutment unable to seat properly at the time of usage.The reported device was not returned for evaluation.Therefore, no conclusion can be drawn that the device malfunctioned.A review of the device history record did not note any non conformance during the manufacturing process.Hence, the reported unit was manufactured to specifications.Since, no product was returned no conclusion can be drawn to the nature of the reported inability to seat properly.(b)(4).Item number: pycma (udi: (b)(4)).

• 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: 15704357
• Report Number: 1060818-2022-13573
• Device Sequence Number: 6584382
• Product Code: NHA
• UDI-Device Identifier: 00847236012113
• UDI-Public: 00847236012113
• 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: PYCMA
• Device Catalogue Number: PYCMA
• Device Lot Number: 2104911
• 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