MAUDE Adverse Event Report: BIOMET 3I 3I T3 TAPERED IMPLANT 6/5 X 8.5MM; DENTAL IMPLANT

Model Number	BOPT6585
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Purulent Discharge (1812); Unspecified Infection (1930); Osteolysis (2377)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported gross granulation tissue noted at the implant site at tooth location #18 as well as purulence seen at the time of implant uncovery.Symptoms as a result of the event: abscess.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient weight unknown / not provided.A summary investigation has been completed for peri-implantitis events recognizing that a definitive root cause cannot be identified due to a wide range of external factors (non-design or manufacturing related), including medical conditions (e.G., diabetes, poor bone quality, etc.) / patient habits (e.G., smoking) and surgical technique.Previously completed investigations for these events have not identified any signals indicating potential non-conformances affecting the manufacturing and sterilization processes.Furthermore, the probability of a manufacturing or design defect that might lead to peri-implantitis occurring and escaping the available detections has been assessed and found remote and almost non-existent.Should additional information be received which indicates that the device may have caused or contributed to the event, an additional report will be submitted.

• Brand Name: 3I T3 TAPERED IMPLANT 6/5 X 8.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 16619025
• Report Number: 0001038806-2023-00598
• Device Sequence Number: 7118094
• Product Code: DZE
• UDI-Device Identifier: 00844868029892
• UDI-Public: (01)00844868029892(17)261129(10)2021110551
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K122300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: BOPT6585
• Device Catalogue Number: BOPT6585
• Device Lot Number: 2021110551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female