MAUDE Adverse Event Report: BIOHORIZONS IMPLANT SYSTEMS BIOHORIZONS IMPLANT SYSTEM MULTI-UNIT ABUTMENTS

Device Problem Material Erosion (1214)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

There were five (5) malfunction events reported indicating the the top of the abutment wore down with time.The reports received did not have a patient adverse event.No information regarding patient demographics was provided as well.

Manufacturer Narrative

There were five (5) malfunction events indicating the top of the abutment being worn down over time.No product was returned for investigation.No physical evaluation may take place.No conclusion may be drawn due to no product being returned.With the events having reported known lot numbers, production documents were reviewed.No known nonconformances were noted.Hence, the conclusion was drawn that the item was manufactured to specifications.Concomitant medical products: 4.5mm multi-unit abutment, 30-degree, 3mm collar.3.5mm multi-unit abutment, 17-degree, 2.25mm collar.3.5mm multi-unit abutment, 17-degree, 3mm collar.3.5mm multi-unit abutment, 17-degree, 4mm collar.3.5mm multi-unit abutment, straight 3mm collar.This report was attempted to submit on (b)(6) 2022.However, due to webtrader system issues, the report would not transmit via webtrader.An esg helpdesk ticket was opened on (b)(6) 2022 covering the issue.The ticket number was (b)(4).Ticket (b)(4) was resolved on (b)(6) 2022.Hence, allowing for the attempt to transmit on (b)(6) 2022.

• Brand Name: BIOHORIZONS IMPLANT SYSTEM MULTI-UNIT ABUTMENTS
• Type of Device: MULTI-UNIT ABUTMENTS
• 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
• MDR Report Key: 14290070
• MDR Text Key: 294801642
• Report Number: 1060818-2022-05041
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Number of Events Reported: 5
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1