MAUDE Adverse Event Report: BIOMET 3I FULL OSSEOTITE® TAPERED CERTAIN® IMPLANT 3.25 X 11.5MM; DENTAL IMPLANT

Model Number	IFNT3211
Medical Device Problem Codes	Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Pain (1994); Osteolysis (2377)
Date of Event	04/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient identifier: (b)(6).A summary investigation has been completed for peri-implantitis events recognizing that a definitive root cause cannot be identified due to a wide range of external factors (non-design or manufacturing related), including medical conditions (e.G., diabetes, poor bone quality, etc.) / patient habits (e.G., smoking) and surgical technique.Previously completed investigations for these events have not identified any signals indicating potential non-conformances affecting the manufacturing and sterilization processes.Furthermore, the probability of a manufacturing or design defect that might lead to peri-implantitis occurring and escaping the available detections has been assessed and found remote and almost nonexistent.Should additional information be received which indicates that the device may have caused or contributed to the event, an additional report will be submitted.
Event or Problem Description
The doctor indicated loss integration at tooth site #12 due to peri-implantitis.There was no adverse reactions after implantation.The patient felt the pain around the implant.After examination, the clinician found that there was inflammation around the implant and the implant was already loose.The implant was removed by the clinician.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: h6: type of investigation code was added: 3331.Dhr review was completed for the subject lot number (2016090577).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Sterilization record (op# (b)(4) was reviewed and verified to have passed all sterilization activities with no issues or nonconformities identified.Complaint history review was performed for the reported lot number (2016090577) for similar events and no other complaint was identified.As documented in the summary investigations, contributing factors for the reported event likely exist outside of zimmer biomet control, including those related to patient biological factors/condition and surgical technique.Based on the summary investigations, no malfunction occurred upon investigation.The reported events remain non-verifiable as they are a medical condition.
Event or Problem Description
No additional event information at the time of this report.

• Brand Name: FULL OSSEOTITE® TAPERED CERTAIN® 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): 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: 12681106
• Report Number: 0001038806-2021-02038
• Device Sequence Number: 3983858
• Product Code: DZE
• UDI-Device Identifier: 00844868004967
• UDI-Public: (01)00844868004967(17)211007(10)2016090577
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K063341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 03/09/2022

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: 10/07/2021
• Device Model Number: IFNT3211
• Device Catalogue Number: IFNT3211
• Device Lot Number: 2016090577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2021
• Supplement Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2016
• 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: 36 YR
• Patient Sex: Male