MAUDE Adverse Event Report: BIOHORIZONS, INC. BIOHORIZONS INTERNAL 4.5MM CUSTOM CASST HEXED ABUTMENT; INTERNAL 4.5MM CUSTOM CAST ABUTMENT

Model Number PGCAH

Device Problem Break (1069)

Patient Problem Missing Value Reason (3192)

Event Type  malfunction  

Manufacturer Narrative

The evaluation concluded the implant connection collar on the abutment has been damaged during the processing of final restoration.Significant grinding damage to the implant connection collar of the abutment.Grinding changes the dimensions and geometry of the specifically designed implant conical connection between the abutment and the implant so that there is no longer a uniform connection around the abutment/implant junction.Because there is no longer a uniform connection, forces will cause the abutment to rock in the junction and apply forces to the hex.The hex is designed to be passive so when acted on by the forces caused by the rocking of the abutment, the hex failed and fractured.

Event Description

Broken custom cast hex abutment.

• Brand Name: BIOHORIZONS INTERNAL 4.5MM CUSTOM CASST HEXED ABUTMENT
• Type of Device: INTERNAL 4.5MM CUSTOM CAST 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
• MDR Report Key: 7611319
• MDR Text Key: 111859578
• Report Number: 1060818-2018-00034
• 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: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: PGCAH
• Device Lot Number: 1404113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1