MAUDE Adverse Event Report: BIOMET 3I FULL OSSEOTITE TAPERED CERTAIN IMPLANT 3.25 X 10MM; DENTAL IMPLANT

Model Number	IFNT3210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	05/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The doctor indicated infection at tooth site #47.The implant was removed due to infection and pain.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Weight unknown / not provided.A summary investigation has been completed for infection events identifying that a definitive root cause cannot be identified due to the wide range of external (non-design/ non-manufacturing related) factors potentially impacting the sterility of the implant and its environment.Should additional information be received which indicates that the device may have caused or contributed to the infection event, an additional report will be submitted.
Event or Problem Description
No additional event information received at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.One full osseotite tapered certain implant 3.25 x 10mm (ifnt3210) was returned for investigation.No malfunction identified.Product inspected and filed.Implant had signs use.Measurements match drawing.No damage identified or signs of malfunction that would contribute to the event.Infection could not be verified.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 (2019090852) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.Products was conforming at the time it left zimvie.Lot was inspected and passed all acceptance criteria by qa.All sterilization activities were conducted with no nonconformities per sterilization record (op0210).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 (2019090852) for similar events and one other complaint was identified.Investigation has identified that the most likely probable causes are related to medical conditions/patient habits and surgical technique.Based on the investigation, risk review and ifu, the most likely cause determined from the investigation is clinician places implant in a patient with patient factors (e.G.Poor hygiene, periodontal issues, pre-existing medical conditions) or inadequate treatment planning.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.

• Brand Name: FULL OSSEOTITE TAPERED CERTAIN IMPLANT 3.25 X 10MM
• 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: 15588712
• Report Number: 0001038806-2022-01545
• Device Sequence Number: 7179493
• Product Code: DZE
• UDI-Device Identifier: 00844868004950
• UDI-Public: (01)00844868004950(17)240919(10)2019090852
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K063341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2023

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 Expiration Date: 09/19/2024
• Device Model Number: IFNT3210
• Device Catalogue Number: IFNT3210
• Device Lot Number: 2019090852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2022
• Supplement Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2019
• 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: 30 YR
• Patient Sex: Female