MAUDE Adverse Event Report: BIOMET 3I 3I T3 TAPERED IMPLANT 6/5 X 10MM; DENTAL IMPLANT

Catalog Number	BOPT6510
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	09/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
It was reported that the implant at tooth site #15 was removed as crown was not seating.General dentist could not seat crown sent to our office.We attempted to seat again & found there is internal distortion.Internal damage, the metal is distorted, meaning it is not its original shape but has been stripped in a way.Symptoms as a result of the event: bone loss.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Zimvie received one (1) bopt6510, (3i t3 tapered implant 6/5 x 10mm) for evaluation.Visual evaluation was performed , slight wear found on the collar and [internal] drive feature however, no damaged drive feature has been identified.Functional testing with an in-house mating component was conducted; a healing abutment seated as intended.Dhr review was completed for the subject lot number 2023030793.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 2023030793 for similar events and no other complaint was identified.Review completed utilizing keywords: dental: functional: damaged drive feature.The customer did not submit images for the reported event.A definitive root cause could not be determined since the device malfunction did not occur, and the reported event has been unconfirmed following functional testing and physical evaluation.Therefore, based on the available information, a device malfunction did not occur.No damage was identified.The reported event was not confirmed.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.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.

• Brand Name: 3I T3 TAPERED IMPLANT 6/5 X 10MM
• 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 20347417
• Report Number: 0001038806-2024-02219
• Device Sequence Number: 8108044
• Product Code: DZE
• UDI-Device Identifier: 00844868029854
• UDI-Public: (01)00844868029854(17)280327(10)2023030793
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: 2024
• 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): 02/18/2025

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: BOPT6510
• Device Lot Number: 2023030793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2024
• 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: 10/01/2024
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2023
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic