MAUDE Adverse Event Report: BIOMET 3I 3I T3 SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT, 5MM(D) X 6MM(L); DENTAL IMPLANT

Model Number	BOES506
Medical Device Problem Codes	Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Sinus Perforation (2277); Osteolysis (2377)
Date of Event	08/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Weight unknown / not provided.Reporter address unknown / not provided.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
The doctor indicated periimplantitis, sinus perforation and loss of integration around the implant at tooth location # 26.The implant was removed.
Event or Problem Description
The distributor confirmed that the "sinus wasn¿t perforated, but the sinus was thin.
Additional Manufacturer Narrative
This report is being submitted to relay corrected data and additional information to the initial mfr report number 0001038806-2022-01509.Upon follow up, the distributor corrected the initial report of "sinus perforation: to "thin sinus".Therefore "sinus perforation" is no longer associated with this report.The following sections are being reported: b4: date of this report was updated.B5: event description was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H6: type of investigation codes were added: 4109 and 4111.H6: investigation findings code was added: 213.H6: investigation conclusions code was added: 4310.H10: narrative/data was updated.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 non-existent.Should additional information be received which indicates that the device may have caused or contributed to the event, an additional report will be submitted.H3 other text : summary investigation.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.D9: device availability and return date was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: type of investigation code was added: 3331.H10: narrative/data was updated.Dhr review was completed for the subject lot number (2020040554).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformance's, 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 (2020040554) 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 received at the time of this report.

• Brand Name: 3I T3 SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT, 5MM(D) X 6MM(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: 15543961
• Report Number: 0001038806-2022-01509
• Device Sequence Number: 20476844
• Product Code: DZE
• UDI-Device Identifier: 00844868033646
• UDI-Public: (01)00844868033646(17)250908(10)2020040554
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150571
• 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: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,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: Lay User/Patient
• Device Expiration Date: 09/08/2025
• Device Model Number: BOES506
• Device Catalogue Number: BOES506
• Device Lot Number: 2020040554
• 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: 10/14/2022; 02/14/2023
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 10/18/2022; 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2020
• 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: 71 YR
• Patient Sex: Male