MAUDE Adverse Event Report: BIOHORIZONS IMPLANT SYSTEMS BIOHORIZONS HEX ABUTMENTS

Model Number TP3MU172

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The product the three (3) malfunction events were not returned for investigation.Therefore, no conclusion may be drawn.A review of the device history record did not reveal any non conformances.Therefore, the conclusion may be drawn that product was manufactured to specifications.With the product beign manufactured to specification, the stripped screw would occur outside of the manufacturers purview.

Event Description

This report summarizes 3 malfunction events.A review of the events involved abutment screws being stripped.No patient consequences were noted for these 6 occurences.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: 10002273
• MDR Text Key: 194364977
• Report Number: 1060818-2020-03202
• 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: 04/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: TP3MU172
• Device Catalogue Number: TP3MU172
• Type of Device Usage: N
• Patient Sequence Number: 1