MAUDE Adverse Event Report: BIOHORIZONS INC. BIOHORIZONS INC.; DENTAL ABUTMENT

Model Number TP3CMAV

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 01/30/2024

Event Type  malfunction  

Event Description

Hex fracture.

• Brand Name: BIOHORIZONS INC.
• Type of Device: DENTAL ABUTMENT
• Manufacturer (Section D): BIOHORIZONS INC.; 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: 18813440
• MDR Text Key: 336614733
• Report Number: 1060818-2024-01137
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TP3CMAV
• Device Catalogue Number: TP3CMAV
• Device Lot Number: 2305761
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention