MAUDE Adverse Event Report: BIOHORIZONS BIOHORIZONS; DENTAL IMPLANT

Model Number	PYSEA
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed to osseointegrate.

• Brand Name: BIOHORIZONS
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOHORIZONS; 2300 riverchase center; birmingham AL 35244
• Manufacturer (Section G): BIOHORIZONS INC; 2300 riverchase center; birmingham AL 35244
• Manufacturer Contact: anissa smith ; 2300 riverchase center; birmingham, AL 35244
• MDR Report Key: 18961240
• Report Number: 1060818-2024-01106
• Device Sequence Number: 7965850
• Product Code: NHA
• UDI-Device Identifier: 00847236006198
• UDI-Public: 00847236006198
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: PYSEA
• Device Catalogue Number: PYSEA
• Device Lot Number: 1907970
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown