MAUDE Adverse Event Report: BIOMET 3I T3¿ PRO TAPERED IMPLANT 5/4MM (D) X 13MM (L); DENTAL IMPLANT

Model Number	T3PT5413
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint (b)(4).Patient weight is not provided / unknown.Initial reporter¿s title is not provided / unknown.
Event or Problem Description
It was reported that the implant was removed due to pain.The patient reported continuous pain at implant site so it was decided to remove the implant.
Additional Manufacturer Narrative
This report is being submitted to report additional information.The following sections are being reported: d4: expiration date and unique identifier (udi) number d9: device availability; h2: if follow-up, what type; h3: device evaluated by manufacturer; h4: device manufacturer date; h6: type of investigation; h6: investigation findings; h6: investigation conclusions; h10: additional narratives/data.The product was returned.However, the reported event could not be verified as the exact details of event were non-verifiable.Based on the evaluation and dimensional analysis, device malfunction has not occurred.Additionally, there is no existing nonconformance / capa / hhe/d / ie / product hold against the reported devices that did or could cause or contribute to the reported event.Monthly post market trending review identified no adverse events or actionable trends for the reported event or devices.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming products.Therefore, based on the available information, the product was within specifications and conforming when it left zimvie.Dhr review for the lot number had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All sterilization activities were conducted with no nonconformities per sterilization record.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming products within specifications.Complaint history review was performed for the reported lot number for similar events and no other complaint was identified.A definitive root cause could not be determined.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.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimvie will continue to monitor for trends.
Event or Problem Description
No additional or corrected information to report.

• Brand Name: T3¿ PRO TAPERED IMPLANT 5/4MM (D) X 13MM (L)
• 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: 15970809
• Report Number: 0001038806-2022-01887
• Device Sequence Number: 14690423
• Product Code: DZE
• UDI-Device Identifier: 00844868046783
• UDI-Public: (01)00844868046783(17)270616(10)2022060094
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K213672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• 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: Lay User/Patient
• Device Model Number: T3PT5413
• Device Catalogue Number: T3PT5413
• Device Lot Number: 2022060094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/28/2022
• Supplement Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2022
• 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: 45 YR
• Patient Sex: Female