MAUDE Adverse Event Report: BIOMET 3I T3 PRO TAPERED IMPLANT 6/5MM (D) X 13MM (L); DENTAL IMPLANT

Catalog Number	T3PT5415
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient called stating there was a bubble on the gum tissue where the implant was placed and the patient was evaluated.A parulis was noted on the facial of site #19.Implant was dull to percussion, implant was removed.Surgical site was thoroughly debrided down to healthy bone.A complete dehiscence of buccal bone was noted.The site was grafted.Symptoms as a result of the event: abscess.
Additional Manufacturer Narrative
Zimvie complaint (b)(4).A summary investigation has been completed for infection events identifying that a definitive root cause cannot be identified due to the wide range of external (non-design/ non-manufacturing related) factors potentially impacting the sterility of the implant and its environment.Should additional information be received which indicates that the device may have caused or contributed to the infection event, an additional report will be submitted.
Additional Manufacturer Narrative
This report is being submitted to report corrected information to 0001038806-2023-02078.Further evaluation of the event revealed that incorrect catalog number was previously reported.The corrected catalog number is now reported.H3 other text : summary investigation.
Event or Problem Description
No additional or corrected information to report.

• Brand Name: T3 PRO TAPERED IMPLANT 6/5MM (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: 18037797
• Report Number: 0001038806-2023-02078
• Device Sequence Number: 12632656
• Product Code: DZE
• UDI-Device Identifier: 00844868046837
• UDI-Public: (01)00844868046837(17)270916(10)2022090367
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: 2023
• 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): 10/31/2023

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 Catalogue Number: T3PT5415
• Device Lot Number: 2022090367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2023
• Is the Reporter a Health Professional?: Yes
• 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: 10/31/2023
• Supplement Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2022
• 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: 51 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic