MAUDE Adverse Event Report: BIOHORIZONS IMPLANT SYSTEMS BIOHORIZONS HEX ABUTMENTS

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

There are a total of 5 malfunction events associated with this report.Product was not returned for investigation for 4 of the 5 reported events.A review of the device history record concluded no noted non-conformances.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 returning unit is under investigation.The physical examination has not concluded as of yet.Therefore, no conclusion may be drawn.The units involved in this report are: item, qty: abutment screw, multi-unit abutment, 2.Biohorizons unknown prosthetic/component: 1.Prosthetic screw, multi-unit, regular: 1.Prosthetic screw, multi-unit, regular (pack of 5): 1.

Event Description

This report summarizes 5 malfunction events.A review of the events involved abutment screws breaking.These reports were received from various sources.No patient consequences were noted for the 5 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: 10353524
• MDR Text Key: 202070504
• Report Number: 1060818-2020-06422
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/31/2020
• Type of Device Usage: N
• Patient Sequence Number: 1