MAUDE Adverse Event Report: BIOMET 3I FULL OSSEOTITE TAPERED IMPLANT 4 X 11.5MM; DENTAL IMPLANT

Catalog Number	FNT411
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Osteolysis (2377)
Date of Event	10/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Doctor reported that implants at tooth sites 16, 14, 12, 22, 24, 32, 43 were removed due to peri-implantitis with inflammation.Patient referred pain.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A1: patient identifier unknown / not provided a2: age at time of event unknown / not provided a4: patient weight unknown / not provided d10: concomitant medical product and therapy dates: fnt411, full osseotite tapered implant 4 x 11.5mm, lot number: 2019071491 3x fnt410, full osseotite tapered implant 4 x 10mm, lot number: 2019080597 xifnt3211, osseotite tapered certain implant 3.25 x 11.5mm, lot number: 2021071447 xifnt411, osseotite tapered certain implant 4 x 11.5mm, lot number: 2021080383 h6: event problem codes - patient code 1932: inflammation 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 nonexistent.Should additional information be received which indicates that the device may have caused or contributed to the event, an additional report will be submitted.H3 other text : summary investigation.

• Brand Name: FULL OSSEOTITE TAPERED IMPLANT 4 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: 19297901
• Report Number: 0001038806-2024-00968
• Device Sequence Number: 5919707
• Product Code: DZE
• UDI-Device Identifier: 00844868003335
• UDI-Public: (01)00844868003335(17)240726(10)2019071491
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063286
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 05/12/2024

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 Expiration Date: 07/25/2024
• Device Catalogue Number: FNT411
• Device Lot Number: 2019071491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL IMPLANT
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic