MAUDE Adverse Event Report: BIOMET 3I T3 PRO NON-PLATFORM SWITCHED TAPERED IMPLANT 4MM (D) X 13MM (L); DENTAL IMPLANT

Catalog Number	T3ST413
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	07/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant at site #12 was removed due to discomfort and pain in area.Site grafted (b)(6) 2022.Patient reported pain in site of implant.When implant was removed, granulated tissue present in osteotomy.Site was debrided.Allograft was placed (b)(6) 2022.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Additional Manufacturer Narrative
Based on updated customer information received and reassessment of the reported event, it was determined that mfr report number 0001038806-2024-00432 was reported in error.Please disregard this submission.No further reports will be submitted for this event.The following sections have been updated: b4: date of this report.G3: date received by manufacturer.G6: checked "follow-up".H2: checked follow-up type.H10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: T3 PRO NON-PLATFORM SWITCHED TAPERED IMPLANT 4MM (D) X 13MM (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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 18879343
• Report Number: 0001038806-2024-00432
• Device Sequence Number: 7919682
• Product Code: DZE
• UDI-Device Identifier: 00844868046936
• UDI-Public: (01)00844868046936(17)270428(10)2022030715
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K213672
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 06/23/2024

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: T3ST413
• Device Lot Number: 2022030715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2024
• 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: 03/11/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2022
• 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: 57 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic