MAUDE Adverse Event Report: BIOHORIZONS IMPLANT SYSTEMS BIOHORIZONS HEX ABUTMENTS

Model Number PXMUAS

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

No product was returned for investigation for the reported malfunction event.A review of the device history record did not reveal any noted non-conformances.Therefore, the conclusion is that the product was manufactured to specifications.Because the product was not returned for physical examination, a conclusion can not be drawn that the product malfunctioned.

Event Description

There is one (1) malfunction event to report.A review of the event involved a loose abutment screw.No patient consequence was noted for the event.No information regarding the demographic of the patient was 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: 10353523
• MDR Text Key: 202063804
• Report Number: 1060818-2020-06423
• 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
• Device Model Number: PXMUAS
• Device Catalogue Number: PXMUAS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/31/2020
• Type of Device Usage: N
• Patient Sequence Number: 1