MAUDE Adverse Event Report: BIOMET 3I 3I T3 TAPERED IMPLANT 5/4 X 8.5MM; DENTAL IMPLANT

Catalog Number	BOPT5485
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Pain (1994)
Date of Event	08/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant at tooth site #unk was removed due to infection.Patient had the complaint of pain / discomfort since implant placement on (b)(6) 2024.Patient was present in the office on (b)(6) 2024 where the implant was removed due to active infection.Symptoms as a result of the event: inflammation, pain.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.E1: last name unknown / not provided.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
The following sections have been updated: b4: date of this report b5.Describe event or problem g3: date received by manufacturer g6: checked "follow-up" h2: checked follow-up type h6: entered evaluation codes h10: added manufacturer narrative.H3 other text : summary investigation.
Event or Problem Description
Customer confirmed tooth #30.

• Brand Name: 3I T3 TAPERED IMPLANT 5/4 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 FL 33410
• Manufacturer Contact: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 20355224
• Report Number: 0001038806-2024-02237
• Device Sequence Number: 7200191
• Product Code: DZE
• UDI-Device Identifier: 00844868028529
• UDI-Public: (01)00844868028529(17)280903(10)2120002861
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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: 2021
• 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): 10/10/2024

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: BOPT5485
• Device Lot Number: 2120002861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2024
• 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: 10/02/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2023
• 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: 47 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic