MAUDE Adverse Event Report: BIOMET 3I 3I T3 WITH DCD NON-PLATFORM SWITCHED TAPERED IMPLANT 3.25 X 11.5MM; DENTAL IMPLANT

Catalog Number	BNST3211
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	03/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced inflammation at implant tooth site #7.The tissue was inflamed, not healing and bleeding.Therefore, the implant was removed.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).E1: reporter last name unknown / not provided product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Zimvie received one (1) bnst3211, (3i t3 with dcd non-platform switched tapered implant 3.25 x 11.5mm) for evaluation.Visual evaluation was performed, slight wear from usage.No damage identified or signs of malfunction.Dhr review was completed for the subject lot number 2022030206.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 2022030206 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : medical : pain.The customer did not submit images for the reported event.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was inadequate treatment planning therefore, based on the available information, a device malfunction did not occur.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: 3I T3 WITH DCD NON-PLATFORM SWITCHED TAPERED IMPLANT 3.25 X 11.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 19195604
• Report Number: 0001038806-2024-00837
• Device Sequence Number: 8361106
• Product Code: DZE
• UDI-Device Identifier: 00844868029106
• UDI-Public: (01)00844868029106(17)270329(10)2022030206
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K122300
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2024

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 Catalogue Number: BNST3211
• Device Lot Number: 2022030206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• 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: 18 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic