MAUDE Adverse Event Report: BIOMET 3I 3I T3¿ WITH DCD¿ NON-PLATFORM SWITCHED TAPERED IMPLANT 3.25 X 15MM; DENTAL IMPLANT

Model Number	BNST3215
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Discomfort (2330); Sensitivity of Teeth (2427)
Date of Event	03/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).A2: age at time of the event unknown / not provided.A4: patient weight unknown / not provided.
Event or Problem Description
Per indicated: site 25 patient complained of sensitivity on adjacent tooth and discomfort at surrounding gums of implant.Symptoms as a result of the event: inflammation and pain.Surgical/medical intervention required for permanent damage: implant removed additional appointment required: yes, new implant placement.Was the procedure completed using another implant or another device? no.
Additional Manufacturer Narrative
Zimvie received one (1) bnst3215, (3i t3® with dcd® non-platform switched tapered implant 3.25 x 15mm) for evaluation.Visual evaluation of the as returned device identified the implant with signs of use, apparent dried blood on internal threads.No damage identified or signs of malfunction were noted that would contribute to the reported event.No failure was identified regarding the returned ismha32.Measurements match drawing.Cal05593632 (due: may 30, 2024).Functional testing to recreate the reported event could not be performed due to the nature of the device & event.This complaint refers to the specific device being investigated for this complaint record.Dhr review was completed for the subject lot number 2020110468.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 2020110468 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿medical other.¿ the customer did not submit images for the reported event.Ifu review: documents reviewed: biomet 3i dental implant ifu p-iis086gi rev.J 2022/08.Information identified: "warnings" & "contraindications" based on the investigation and risk management file review as per rmf rm-00053-haz rev.11, the most likely root causes determined from the investigation are missing or confusing instructions for use, clinician places implant in a patient with patient factors (e.G.Poor bone quality, poor patient hygiene, periodontal issues, preexisting medical conditions) incompatible with osseointegration of implant.Therefore, based on the available information, a device malfunction did not occur.The reported event was non-verifiable with all the available information.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was 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 available at the time of this report.

• Brand Name: 3I T3¿ WITH DCD¿ NON-PLATFORM SWITCHED TAPERED IMPLANT 3.25 X 15MM
• 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 ; 5619713230
• MDR Report Key: 17133185
• Report Number: 0001038806-2023-01159
• Device Sequence Number: 6400340
• Product Code: DZE
• UDI-Device Identifier: 00844868029120
• UDI-Public: (01)00844868029120(17)251203(10)2020110468
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2023

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: Other
• Device Expiration Date: 12/03/2025
• Device Model Number: BNST3215
• Device Catalogue Number: BNST3215
• Device Lot Number: 2020110468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2023
• 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: 05/23/2023
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic