MAUDE Adverse Event Report: BIOHORIZONS IMPLANT SYSTEMS BIOHORIZONS ABUTMENT

Model Number ABUTMENT

Device Problems Break (1069); Structural Problem (2506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

No product was returned for investigation.Therefore, no conclusion may be drawn.

Event Description

This report summarize 1 malfunction event.A review of the event involved hexed abutment being stripped.No patient consequences were noted for these 6 occurences.No information regarding the demographics of the patients were provided.

• Brand Name: BIOHORIZONS ABUTMENT
• Type of Device: BIOHORIZONS ABUTMENT
• 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 ; 2059867880
• MDR Report Key: 9251300
• MDR Text Key: 165396844
• Report Number: 1060818-2019-02360
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ABUTMENT
• Type of Device Usage: N
• Patient Sequence Number: 1