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

Model Number PYCAH

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

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Manufacturing defects/deformation - no defects identified as a result of the manufacturing process.No deformations or damages identified as a result of the manufacturing process.End user physical damage - the abutment was overcast so that casting material flowed over the implant connection collar.This was attempted to be resolved by grinding the material away, which a) they did not get all of it so there was still over casted material on the implant connection collar and b) they grinded away portions of the implant connection collar investigation results and conclusions - the implant connection collar on the abutment has been damaged during the processing of the final restoration.Overcasting and 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.There should never be overcasting past the collar of the abutment.There should never be grinding of the collar of the abutment.Failure caused by improper technique or improper use of product.

Event Description

Hex broke off abutment.

• Brand Name: BIOHORIZONS INTERNAL 3.5MM CUSTOM CAST ABUTMENT, HEXED
• Type of Device: INTERNAL 3.5MM CUSTOM CAST ABUTMENT, HEXED
• 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: 8381666
• MDR Text Key: 138160858
• Report Number: 1060818-2018-00124
• 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: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PYCAH
• Device Lot Number: 1502509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2015
• 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