MAUDE Adverse Event Report: BIOHORIZONS IMPLANT SYSTEMS BIOHORIZONS IMPLANT SYSTEM MULTI-UNIT ABUTMENT; MULTI-UNIT IMPLAN ABUTMENT

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

There were three (3) malfunction events reported associated with the abutments becoming loose during usage.All three (3) of the devices were not returned for investigation.Therefore, no conclusion may be drawn to the cause of the reported failure.The reported devices included known lot numbers.Because the lot numbers were reported a review of the production devices was reviewed.No nonconformances were noted from the production documents.Therefore, the conclusion was drawn that the devices were manufactured to specifications.Medical devices: biohorizons multi-unit straight abutment for conelog, ø3.8/4.3 x 2mm (gh).Biohorizons multi-unit straight abutment for conelog, ø3.8/4.3 x 3mm (gh).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 (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.

Event Description

This report summarizes three (3) malfunction events.A review of the events involves an abutment becoming loose during usage.The reports were received with no patient adverse events.No information regarding patient demographics was provided as well.

• Brand Name: BIOHORIZONS IMPLANT SYSTEM MULTI-UNIT ABUTMENT
• Type of Device: MULTI-UNIT IMPLAN 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
• MDR Report Key: 14289893
• MDR Text Key: 294533108
• Report Number: 1060818-2022-05038
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Number of Events Reported: 3
• 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