MAUDE Adverse Event Report: BIOHORIZONS IMPLANT SYSTEMS BIOHORIZONS HEX ABUTMENTS

Device Problem Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

There are a total of 3 malfunction events associated with this report.Product was not returned for investigation for 2 of the 3 reported events.A review of the device history record concluded no noted nonconformances.Therefore, one may conclude the device was manufactured to specifications.However, because no product was returned for investigation no conclusion may be drawn against the product malfunctioning.Product was returned for the remaining one (1) unit for investigation.The investigation concluded the abutment screw passed an ivt test.The physical examination revealed the item did not appear to be stripped.The investigation revealed the item function as designed.There was no evidence to support the product was not manufactured to specifications.Hence, the conclusion is that the product did not malfunction.The units involved in this report are: item: abutment screw, multi-unit abutment: qty: 1.Prosthetic screw, multi-unit, regular: 2.

Event Description

This report summarizes 3 malfunction events.A review of the events involved abutment screws stripping.These reports were received from various sources.No patient consequences were noted for the 3 events.No information regarding the demographics of the patients were 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: 10353527
• MDR Text Key: 202063816
• Report Number: 1060818-2020-06424
• 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