MAUDE Adverse Event Report: BIOMET 3I 3I T3 TAPERED IMPLANT 4/3 X 15MM; DENTAL IMPLANT

Model Number	BOPT4315
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant at tooth site #5 was removed due to pain.Patient initially felt pain on implant when general dentist was trying to deliver crown.Pain upon pressure and tightening.Implant was removed on (b)(6)2022. symptoms as a result of the event: pain.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.
Additional Manufacturer Narrative
Zimvie did not receive one (1) bopt4315, (3i t3® tapered implant 4/3 x 15mm) for evaluation.Visual inspection could not be performed.The investigation has been performed based on the available information using the item number, device history record (dhr) review, and risk management file (rmf).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 2020120818.No deviations or non-conformance's, 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 2020120818 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿pain.¿ 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 cause determined from the investigation is 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 could not be verified.Without device receipt, the reported event is non-verifiable.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.The following sections have been updated: b4: date of this report g3: date received by manufacturer g6: checked "follow-up" h2: checked follow-up type h3: changed "yes" to "no" h6: entered evaluation codes h10: added manufacturer narrative h3 other text : device was not returned.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: 3I T3 TAPERED IMPLANT 4/3 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 ; 5617766700
• MDR Report Key: 16916139
• Report Number: 0001038806-2023-00904
• Device Sequence Number: 2098841
• Product Code: DZE
• UDI-Device Identifier: 00844868029908
• UDI-Public: (01)00844868029908(17)260115(10)2020120818
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2023

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: 01/15/2026
• Device Model Number: BOPT4315
• Device Catalogue Number: BOPT4315
• Device Lot Number: 2020120818
• Was Device Available for Evaluation?: No
• 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: 04/21/2023
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic