MAUDE Adverse Event Report: BIOHORIZONS IMPLANT SYSTEMS BIOHORIZONS HEX ABUTMENTS

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

There was a total of 57 malfunction events associated with breakage or fracture of an abutment hex.21 of the 57 units were not returned for investigation.Since no product was returned for investigation, no conclusion can be drawn.A review of the device history record did not reveal any noted nonconformances.Hence, the conclusion was determined the device was manufactured to specifications.34 of the 57 units were returned for investigation for evaluation.22 of the 34 units were either damaged or misused by the end user.3 of the 34 units are pending investigation.4 of the 34 functioned as designed.Hence, no device impact connected to the malfunction.5 of the 34 units evaluated could not determine the cause of breakage.A device history record review did not reveal any nonconformances of reported and returned product.The evaluation of the 34 returned units determined 3 of them were not manufactured by biohorizons.The evaluation also noted the devices returned were broken or fractured.A fractured/broken abutment can occur due to the unit being over torqued during the restoration phase of the implant surgery completion procedure.Items involved: 3.0mm multi-unit abutment, 17-degree, 2.25mm collar; 3.0mm multi-unit abutment, straight 3mm collar; 3.5mm multi-unit abutment, 17-degree, 3mm collar; 3.5mm multi-unit abutment, 30-degree, 3mm collar; 3.5mm multi-unit abutment, 30-degree, 5mm collar; 3.5mm multi-unit abutment, straight 2mm collar; 4.5mm custom milled abutment; 4.5mm multi-unit abutment, 17-degree, 4mm collar; 5.7mm custom milled abutment.Biohorizons unknown prosthetic/component: internal 3.5mm custom cast abutment, hexed.Internal 4.5mm custom cast abutment, hexed.

Event Description

This report summarizes 57 malfunction events.A review of the events involved abutment hexes breaking or fracturing.These reports were received from various sources.No patient consequences were noted for the 57 events.No information regarding the patient demographics were provided.

• Brand Name: BIOHORIZONS HEX ABUTMENTS
• Type of Device: HEX ABUTMENTS
• Manufacturer (Section D): BIOHORIZONS IMPLANT SYSTEMS; 2300 riverchase center; birmingham AL 35244
• Manufacturer (Section G): BIOHORIZONS IMPLANT SYSTEMS; 2300 riverchase center; birmingham AL 35244
• Manufacturer Contact: anissa smith ; 2300 riverchase center; birmingham, AL 35244
• MDR Report Key: 11752154
• MDR Text Key: 250469615
• Report Number: 1060818-2021-03777
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Number of Events Reported: 57
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1