MAUDE Adverse Event Report: BIOHORIZONS, INC. BIOHORIZONS INTERNAL 4.5MM ANGLE ESTHETIC ABUTMENT; INTERNAL 4.5MM ANGEL ESTHETIC

Model Number PYAEA

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The return included pyaea with a fractured hex.The hex segment was not returned for examination to allow for better understanding if the failure is a result of overtorque or possibly high forces applied to the prosthetic component during use.Since no details were provided on the conditions under which the abutment failed, the disposition could not be determined.

Event Description

Hex broke off abutment.

• Brand Name: BIOHORIZONS INTERNAL 4.5MM ANGLE ESTHETIC ABUTMENT
• Type of Device: INTERNAL 4.5MM ANGEL ESTHETIC
• Manufacturer (Section D): BIOHORIZONS, INC.; 2300 riverchase center; birmingham 35244
• Manufacturer (Section G): BIOHORIZONS, INC.; 2300 riverchase center; birmingham 35244
• Manufacturer Contact: anissa smith ; 2300 riverchase center; birmingham 35244 ; 2059867880
• MDR Report Key: 7822102
• MDR Text Key: 118553402
• Report Number: 1060818-2018-00077
• Device Sequence Number: 1
• Product Code: NHA
• 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: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PYAEA
• Device Lot Number: 1300703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1