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

Device Problem Unintended Compatibility (4047)

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

Event Type  malfunction  

Event Description

This report provides information for ten (10) malfunction events.A review of the events involves abutments experiencing engagement issues.The reports received were from various sources.No patient adverse events were reported.Additionally, no information regarding patient demographics was provided.

Manufacturer Narrative

There were ten (10) malfunction events reported.There were ten malfunction events reported for engagement issues in an implant.The devices were returned for evaluation.Each complaint investigation with a reported lot number had the production records reviewed for nonconformances occurring during the manufacturing process.Therefore, a conclusion is that the device was manufactured to specifications.For devices that did not have a known lot number provided otherwise listed as unknown, then, no review may take place of the production documentation.However, because the units were returned for evaluation, no manufacturing defects were noted.2 of the 10 reported complaint investigations are pending investigations/evaluations.No conclusion can be drawn until the evaluation has been performed.2 of the 10 reported complaint investigations were determined to be misused by the end-user.The misuse can contribute to the device failing.1 of the 10 reported complaint investigations was determined to be damaged by the end-user.The damage to the abutment can contribute to the device's failure.3 of the 10 reported complaint investigations could not determine the failure cause reported.2 of the 10 reported passed an ivt test.Therefore, the product did function as designed.Devices returned - internal 3.5 wide healing abutment, 5mm height, 3.0mm multi-unit abutment, straight 3mm collar, 3.5mm multi-unit abutment, straight 1mm collar, 3.5mm multi-unit abutment, 30-degree, 3mm collar, 4.5mm multi-unit abutment, 30-degree, 4mm collar, 4.5mm multi-unit abutment, straight 1mm collar, 4.5mm multi-unit abutment, straight 2mm collar.This report was attempted to submit on 04/29/2022.However, due to webtrader system issues, the report would not transmit via webtrader.An esg helpdesk ticket was opened on 04/29/2022 covering the issue.The ticket number was (b)(4).Ticket (b)(4) was resolved on 05/03/2022.Hence, allowing for the attempt to transmit on 05/04/2022.

• Brand Name: BIOHORIZONS IMPLANT 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: 14289708
• MDR Text Key: 293352842
• Report Number: 1060818-2022-05034
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Number of Events Reported: 10
• 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 the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1