MAUDE Adverse Event Report: BIOMET 3I 3I T3 TAPERED IMPLANT 6/5 X 11.5MM; DENTAL IMPLANT

Catalog Number	BOPT6511
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	08/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant at tooth location #19 was exfoliated and was removed due to bone loss.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).A summary investigation has been completed for bone loss 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 bone loss have not identified any signals indicating potential non-conformances affecting the manufacturing and sterilization processes.Furthermore, the probability of manufacturing or design defects that might lead to bone loss 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.
Event or Problem Description
Based on additional information received, the implant exfoliated two (2) weeks after placement due to non-integration.There was no injury, significant delay and no alleged failure of the device.Therefore, this event does not meet the definition of a reportable event.As a result, the prior submissions for mfr- submitted on december 4, 2023 is no longer considered a reportable event by the manufacture and no further reports will be submitted for this event.
Additional Manufacturer Narrative
This report is being submitted to relay corrected data and additional information.This report is being submitted to retract the initial report, mfr report number that was submitted on december 4, 2023.Based on additional information received, the implant exfoliated two (2) weeks after placement due to non-integration.Therefore, this report is no longer considered a reportable event by the manufacture and no further reports will be submitted for this event.The following sections are being reported: b4: date of this report was updated.B5: event description was updated.D6a: implant placement date was updated.D6b: implant explant date was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H10: narrative/data was updated.

• Brand Name: 3I T3 TAPERED IMPLANT 6/5 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 ; 5619713230
• MDR Report Key: 18255961
• Report Number: 0001038806-2023-02347
• Device Sequence Number: 15103307
• Product Code: DZE
• UDI-Device Identifier: 00844868029861
• UDI-Public: (01)00844868029861(17)270411(10)2022031440
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K122300
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2024

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 Catalogue Number: BOPT6511
• Device Lot Number: 2022031440
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 05/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2022
• 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: 60 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic