MAUDE Adverse Event Report: BIOHORIZONS, INC. BIOHORIZON INTERNAL 3.5MM LASER - LOK TITANIUM BASE ABUTMENT; INTERNAL 3.5MM TITANIUM BASE

Model Number PYTBL

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

No deformations or damages identified as a result of the manufacturing process.The hex has broken off of the abutment.There is grinding damage to the implant/abutment collar.The implant connection collar on the abutment has been damaged during the processing of the final restoration.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.Failure caused by improper technique or improper use of product.

Event Description

Abutment hex broke in half.

• Brand Name: BIOHORIZON INTERNAL 3.5MM LASER - LOK TITANIUM BASE ABUTMENT
• Type of Device: INTERNAL 3.5MM TITANIUM BASE
• 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: 7822105
• MDR Text Key: 118544443
• Report Number: 1060818-2010-00079
• 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: PYTBL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• 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