MAUDE Adverse Event Report: BIOHORIZONS IMPLANT SYSTEMS BIOHORIZONS ABUTMENT; INTERNAL ABUTMENT

Model Number PYMU303

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

This report provides three (3) malfunction event.A review of the event involved a reported fractured or broken of the reported item.No patient adverse event(s) were reported.No information regarding patient demographics were provided.

• Brand Name: BIOHORIZONS ABUTMENT
• Type of Device: INTERNAL 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
• MDR Report Key: 18619556
• MDR Text Key: 334256432
• Report Number: 1060818-2023-19638
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 00847236006754
• UDI-Public: 00847236006754
• Combination Product (y/n): N
• Number of Events Reported: 3
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PYMU303
• Device Catalogue Number: PYMU303
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1