MAUDE Adverse Event Report: BIOMET 3I 3I T3® NON-PLATFORM SWITCHED PARALLEL WALLED IMPLANT 3.25 X 13MM; DENTAL IMPLANT

Model Number	BOSS313
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	08/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Patient weight not provided.
Event or Problem Description
It was reported that the implant would not seat due to buccal bone loss at the site.The procedure was not completed using another device.
Event or Problem Description
Upon follow up with doctor it was indicated that the implant lack of primary stability and therefore was unable to complete the procedure due to poor bone quality.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Due to the update on complaint description this event would no longer be considered reportable and therefore no additional reports would be submitted under mfr-0001038806-2022-01459.

• Brand Name: 3I T3® NON-PLATFORM SWITCHED PARALLEL WALLED IMPLANT 3.25 X 13MM
• 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 ; 5617766700
• MDR Report Key: 15454699
• Report Number: 0001038806-2022-01459
• Device Sequence Number: 17862646
• Product Code: DZE
• UDI-Device Identifier: 00844868028772
• UDI-Public: (01)00844868028772(17)270524(10)2022050623
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K122300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2023

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 Model Number: BOSS313
• Device Catalogue Number: BOSS313
• Device Lot Number: 2022050623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2022
• Supplement Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 09/20/2022
• Supplement Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2022
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male