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

Model Number TP3MU1

Device Problem Material Integrity Problem (2978)

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

Event Type  malfunction  

Manufacturer Narrative

There was one (1) malfunction event reported.There was one malfunction event reported for damaged threads.From the product evaluation, it has been determined the damaged threads were present.The prosthetic screw was used in an ivt and failed.This is what caused the damaged threads.The root cause could not be identified due to a lack of information on the usage of the returned device.Because the known lot number was not reported or determined, a review of production documents could not be determined.Device returned - 3.0mm multi-unit abutment, straight 1mm 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.

Event Description

This report provides information for one (1) malfunction event.A review of the event involves an abutment having damaged threads.The report was received with no patient adverse events.No information regarding patient demographics was provided.

• Brand Name: BIOHORIZONS MULTI-UNIT ABUTMENT
• Type of Device: MULTI-UNIT 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: 14290008
• MDR Text Key: 293352568
• Report Number: 1060818-2022-05033
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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
• Device Model Number: TP3MU1
• Device Catalogue Number: TP3MU1
• Device Lot Number: UNKNOWN
• 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