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

Model Number PGCAH

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

No defects identified as a result of the manufacturing process.No deformations or damages identified as a result of the manufacturing process.The implant connection collar on the abutment has been completely redefined during processing.The geometry of the implant connection collar on the abutment has been completely altered during the processing of the final restoration.The dimensions and geometry of the implant conical connection between the abutment and the implant are designed so that there is 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.Failure caused by improper technique or improper use of product.

Event Description

Hex broke off abutment.

• Brand Name: BIOHORIZON INTERNAL 4.5MM CUSTOM CAST ABUTMENT, HEXED
• 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 ; 2059867880
• MDR Report Key: 7822093
• MDR Text Key: 118553356
• Report Number: 1060818-2018-00073
• 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: PGCAH
• Device Lot Number: 1407334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2014
• 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