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

Model Number PGCAH

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

No deformation/damage as result of manufacturing identified.No defects as a result of manufacturing identified.The returned pgcah was attached to a crown with a fractured hex and fractured pxas.The hex segment was not returned for examination.The bevel of the abutment appears to have been compromised (1) by the crown going down almost to where the abutments sits onto the implant and (2) polishing and prepping.It is very important to maintain the bevel where the abutment sits on the implant unmodified to ensure appropriate seating and seal between the components.The modification to the abutment bevel may have compromised the seat between the components.Failure caused by improper technique or improper use of product.

Event Description

Hex broke off of abutment.

• Brand Name: BIOHORIZON INTERNAL 4.5MM CUSTOM
• 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: 7822094
• MDR Text Key: 118536922
• Report Number: 1060818-2018-00074
• 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?: No
• Device Operator: Health Professional
• Device Model Number: PGCAH
• Device Lot Number: 1505827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2015
• 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