MAUDE Adverse Event Report: BIOMET 3I 3I T3 NON-PLATFORM SWITCHED TAPERED IMPLANT 3.25 X 8.5MM; DENTAL IMPLANT

Catalog Number	BOST3285
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	09/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A2: age at time of event unknown / not provided.A4: patient weight unknown / not provided.D9: device availability unknown / not provided.D10: concomitant medical product and therapy dates: 2 x bost3210, 3i t3 non-platform switched tapered implant 3.25 x 10mm, lot number: 2023020473.
Event or Problem Description
It was reported that the implants at tooth sites 14, 24 and 26 were removed due to bone loss.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report; b5: describe event or problem; d9: device availability ; g3: date received by manufacturer; g6: type of report; h1: type of reportable event; h2: follow up type; h3: device evaluated by manufacturer; h6: adverse event problem; h10: additional narrative.Dhr review was completed for the subject lot number 2022021073.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 2022021073, for similar events and no other complaint was identified.Review completed utilizing keywords: dental : medical : bone loss.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 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
No further event information is available at the time of this report.

• Brand Name: 3I T3 NON-PLATFORM SWITCHED TAPERED IMPLANT 3.25 X 8.5MM
• 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: 18442445
• Report Number: 0001038806-2024-02564
• Device Sequence Number: 6751918
• Product Code: DZE
• UDI-Device Identifier: 00844868028918
• UDI-Public: (01)00844868028918(17)270315(10)2022021073
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2024

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: Lay User/Patient
• Device Catalogue Number: BOST3285
• Device Lot Number: 2022021073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2022
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL IMPLANT.; DENTAL IMPLANT.
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic