MAUDE Adverse Event Report: BIOMET 3I FULL OSSEOTITE TAPERED CERTAIN IMPLANT 4 X 8.5MM; DENTAL IMPLANT

Model Number	IFNT485
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Inflammation (1932); No Code Available (3191)
Date of Event	10/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).Patient id: (b)(6).Weight unknown / not provided.Fax number unknown / not provided.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-conformance's 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
It was reported that the patient experienced peri-implantitis, loss integration, inflammation around the implant and edema.The implant was removed.Tooth #3.
Additional Manufacturer Narrative
This report is being submitted to relay corrected data and additional information.Associated lot #2014031343 was manufactured prior to 24-sep-2015, as a result, a udi number is not required.The following sections are being reported: h6: component code was added: 4755.
Event or Problem Description
No additional event information at the time of this report.
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.The following sections are being reported: b4: date of this report was updated.D9: device availability was added.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H6: type of investigation code was added: 3331 h10: narrative/data was updated.Dhr review was completed for the subject lot number (2014031343).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#0210) 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 (2014031343) 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.

• Brand Name: FULL OSSEOTITE TAPERED CERTAIN IMPLANT 4 X 8.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11005473
• Report Number: 0001038806-2020-02048
• Device Sequence Number: 11822698
• Product Code: DZE
• UDI-Device Identifier: 00844868005049
• UDI-Public: (01)00844868005049(17)190327(10)2014031343(241)IFNT485
• 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: 2018
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2021

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 Expiration Date: 03/27/2019
• Device Model Number: IFNT485
• Device Catalogue Number: IFNT485
• Device Lot Number: 2014031343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 03/02/2021; 04/11/2021
• Initial Report FDA Received Date: 12/14/2020
• Supplement Report FDA Received Date: 03/02/2021; 04/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR