MAUDE Adverse Event Report: BIOHORIZONS IMPLANT SYSTEMS BIOHORIZONS HEX ABUTMENTS

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

There are a total of 2 malfunction events associated with this report.The products for both malfunction events are returned for investigation with a report of defective.These investigations are in progress.Because the investigations are in progress and having limited information of "defective," no conclusion may be drawn that the returning units malfunctioned.The units involved in this report are : item: 3.5mm multi-unit abutment, 17-degree, 2.25mm collar: qty: 1.Unknown prosthetic/component: 1.

Event Description

This report summarizes 2 malfunction events.A review of the events indicates the abutments are defective.The reports were received from various sources.No patient consequences were noted for the 2 events.No information regarding the demographics of the patients provided.

• Brand Name: BIOHORIZONS HEX ABUTMENTS
• Type of Device: HEX ABUTMENTS
• Manufacturer (Section D): BIOHORIZONS IMPLANT SYSTEMS; 2300 riverchase center; birmingham, al
• Manufacturer (Section G): BIOHORIZONS IMPLANT SYSTEMS; 2300 riverchase center; birmingham, al
• Manufacturer Contact: anissa smith ; 2300 riverchase center; birmingham, al ; 9867880
• MDR Report Key: 10353528
• MDR Text Key: 202085601
• Report Number: 1060818-2020-06425
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1