MAUDE Adverse Event Report: BIOMET 3I 3I T3¿ TAPERED IMPLANT 6/5 X 8.5MM; DENTAL IMPLANT

Catalog Number	BOPT6585
Medical Device Problem Codes	No Flow (2991); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	04/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant was removed due to bone loss.Symptoms as a result of the event: abscess & inflammation site grafted: allograft.
Additional Manufacturer Narrative
Zimvie complaint: (b)(4).A4: patient weight is not provided / unknown.B3: date of event is not provided / unknown.E1: initial reporter¿s title is not provided / unknown.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.H3 other text : summary investigation.
Additional Manufacturer Narrative
This report is being submitted to report both corrected and additional information to 0001038806-2023-01387.Review of the initial report confirmed that the h6: device code was reported incorrectly.It is now being reported correctly.Dhr review was completed for the subject lot number.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 for similar events and no other complaint was identified.A definitive root cause could not be determined.Based on the investigation, no malfunction occurred upon investigation and no association between the dental implant and bone loss was found that can explain these events.Therefore, the reported event remains non-verifiable as it is a medical condition.Monthly trending to date has not identified any statistical triggers suggesting potential design or manufacturing related issues.Previously completed investigations for bone loss problems reported in association with implant failure have not identified any signals indicating potential non-conformances impacting the manufacturing and sterilization processes.Therefore, escalation to capa is not required.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.
Event or Problem Description
No additional or corrected information to report.

• Brand Name: 3I T3¿ TAPERED IMPLANT 6/5 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 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 17393299
• Report Number: 0001038806-2023-01387
• Device Sequence Number: 8978760
• Product Code: DZE
• UDI-Device Identifier: 00844868029892
• UDI-Public: (01)00844868029892(17)260615(10)2021051433
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/25/2023

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: 06/14/2026
• Device Catalogue Number: BOPT6585
• Device Lot Number: 2021051433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/25/2023
• Supplement Report FDA Received Date: 12/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2021
• 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: 41 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic