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

Model Number	IFNT411
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Edema (1820); Unspecified Infection (1930); Inflammation (1932); Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Date of event unknown / not provided.A summary investigation has been completed for bone loss 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 bone loss have not identified any signals indicating potential non-conformances affecting the manufacturing and sterilization processes.Furthermore, the probability of manufacturing or design defects that might lead to bone loss and escaping the available detections has been assessed and found remote and almost nonexistent.A summary investigation has also 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 event, an additional report will be submitted.Summary reporting.
Event or Problem Description
It was reported that clinician indicated infection, bone loss.Patient return with inflammation, pain, edema, abscess.Tooth site # 8.

• Brand Name: FULL OSSEOTITE TAPERED CERTAIN IMPLANT 4 X 11.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11172843
• Report Number: 0001038806-2021-00078
• Device Sequence Number: 16781891
• Product Code: DZE
• UDI-Device Identifier: 00844868005018
• UDI-Public: (01)00844868005018(17)240418(10)2019040849(241)IFNT411
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K063341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 01/14/2021

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: 04/18/2024
• Device Model Number: IFNT411
• Device Catalogue Number: IFNT411
• Device Lot Number: 2019040849
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 01/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Weight: 60