MAUDE Adverse Event Report: BIOHORIZONS, INC. BIOHORIZONS INTERNAL 3.5MM CUSTOM CAST ABUTMENT - HEXED

Model Number PYCAH

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The abutment is not being returned for evaluation/investigation.Therefore, no conclusion can be drawn as to the what caused the hex to fracture.Device not returned for evaluation.

Event Description

The hex broke off the abutment.

• Brand Name: BIOHORIZONS INTERNAL 3.5MM CUSTOM CAST ABUTMENT - HEXED
• Type of Device: INTERNAL 3.5MM CUSTOM CAST 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 ; 2059867888
• MDR Report Key: 7346003
• MDR Text Key: 103042587
• Report Number: 1060818-2018-00009
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PYCAH
• Device Catalogue Number: PYCA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1