MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® CERTAIN® 2 IMPLANT 5 X 11.5MM; DENTAL IMPLANT

Catalog Number	XIFOSS511
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Osteolysis (2377)
Date of Event	11/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant at tooth site #22 was removed due to peri-implantitis.
Additional Manufacturer Narrative
Zimvie complaint number: (b)(4).A4: weight unknown / not provided.A summary investigation has been completed for peri-implantitis events recognizing that a definitive root cause cannot be identified due to a wide range of external factors (non-design or manufacturing related), including medical conditions (e.G., diabetes, poor bone quality, etc.) / patient habits (e.G., smoking) and surgical technique.Previously completed investigations for these events have not identified any signals indicating potential non-conformances affecting the manufacturing and sterilization processes.Furthermore, the probability of a manufacturing or design defect that might lead to peri-implantitis occurring and escaping the available detections has been assessed and found remote and almost non-existent.Should additional information be received which indicates that the device may have caused or contributed to the event, an additional report will be submitted.
Additional Manufacturer Narrative
H10: this report is being submitted to relay corrected data.Correction; g3.Date received by manufacturer: 1/2/2025.The following sections are being reported: g3: date received by manufacturer was updated.H2: type of follow up was updated.H10: narrative/data was updated.
Event or Problem Description
No additional event information received at the time of this report.

• Brand Name: OSSEOTITE® CERTAIN® 2 IMPLANT 5 X 11.5MM
• 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: 21211034
• Report Number: 0001038806-2025-00167
• Device Sequence Number: 8070440
• Product Code: DZE
• UDI-Device Identifier: 00844868023159
• UDI-Public: (01)00844868023159(17)230412(10)2018031696
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K100724
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 01/21/2025

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 Expiration Date: 04/11/2023
• Device Catalogue Number: XIFOSS511
• Device Lot Number: 2018031696
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/01/2025
• 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: 01/22/2025
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2025
• 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: 55 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic