MAUDE Adverse Event Report: BIOHORIZONS, INC. BIOHORIZONS INTERNAL 3.5MM BULK PREP ABUTMENT

Model Number PYBPA

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The return included pybpa with a fractured hex.The bevel of the abutment where it sits onto the implant did not appear to be overpolished.The hex segment was returned for examination and no signs of overtorqueing were apparent.The abutment was attached to a crown with a captured pxas.The screw could not be removed as the thru hole into the crown was blocked.The pxas screw was not fractured.It is not clear if the failure is a result of excessive forces applied to the prosthesis during use.No information was provided on patient's habits to clarify the conditions under which the abutment has fractured.

Event Description

Broken abutment.

• Brand Name: BIOHORIZONS INTERNAL 3.5MM BULK PREP ABUTMENT
• Type of Device: INTERNAL 3.5MM BULK PREP ABUTMENT
• 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: 7807343
• MDR Text Key: 118103081
• Report Number: 1060818-2018-00064
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PYBPA
• Device Lot Number: 1800324
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1