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

Model Number PGCAH

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

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

No deformation/damage as a result of the manufacturing process identified.Physical damage due to end use results - the hex is fractured at the junction of the hex and abutment body.The prosthetic connection feature is irregular in shape.Investigation comments - the irregularities of the prosthetic connection bevel is consistent with the component being modified (e.G.Polished, ground, sand blasted, material flow) at the laboratory.The prosthetic connection is not to be modified and is required to be protected during laboratory post processes such as polishing.Implant analogs are recommended to be used for laboratory post processing of prosthetics.Failure to do so can lead to improper/incomplete seating and can subject the hex interface and/or abutment screw directly to occlusal forces.Investigation results and conclusions - failure caused by improper technique or improper use of product.

Event Description

Hex broke off abutment.

• Brand Name: BIOHORIZONS INTERNAL 4.5MM CUSTOM CAST ABUTMENT, HEXED
• Type of Device: 4.5MM INTERNAL 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: 8265119
• MDR Text Key: 135174101
• Report Number: 1060818-2018-00095
• 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: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2019
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• 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