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 Code	Pain (1994)
Date of Event	07/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient reported pain in area of the implant at tooth site #12.Granulation tissue was present in the osteotomy area, therefore the implant was removed and the area was debrided.
Additional Manufacturer Narrative
This report is being submitted to relay corrected data and additional information correction: the initial report, mfr report number 0001038806-2024-00160 that was submitted on february 1, 2023 is a duplicate of mfr report number 0001038806-2023-00592 that was submitted on march 27, 2023.Therefore, this supplemental mw is being submitted as a retraction due to duplication.All details regarding this event have been processed and completed under mfr report number 0001038806-2023-00592.No additional reports will be submitted under mfr report number 0001038806-2024-00160.The following sections are being reported: b4: date of this report was updated.B5: event description was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H10: narrative/data was updated.
Event or Problem Description
This report is being submitted to retract the initial report, mfr report number 0001038806-2024-00160 that was submitted on february 1, 2023 as this event is a duplicate of mfr report number 0001038806-2023-00592 that was submitted on march 27, 2023.

• 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 18624180
• Report Number: 0001038806-2024-00160
• Device Sequence Number: 18059414
• 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: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2024

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: T3ST413
• Device Lot Number: 2022030715
• Was Device Available for Evaluation?: No
• 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: 02/01/2024
• Supplement Report FDA Received Date: 07/17/2024
• 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