MAUDE Adverse Event Report: BIOMET 3I FULL OSSEOTITE® TAPERED CERTAIN® IMPLANT 4 X 10MM; DENTAL IMPLANT

Model Number	IFNT410
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932)
Date of Event	03/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).Weight unknown / not provided.Infection: 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.
Event or Problem Description
It was reported that the patient had an infection.The implant was subsequently removed.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).A device history record review was performed and no related deviations or nonconformances were noted.Also, a complaint history search was performed using our complaint handling system and there were two additional related complaints for this product lot.Sterilization record was reviewed and verified to have passed all sterilization activities with no issues or nonconformities identified.The following sections have been updated: d9: device available for evaluation change ¿no' to 'yes.' h3: device evaluated by manufacturer: change ¿no' to 'yes.'.

• Brand Name: FULL OSSEOTITE® TAPERED CERTAIN® IMPLANT 4 X 10MM
• 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: 12216584
• Report Number: 0001038806-2021-01359
• Device Sequence Number: 4136493
• Product Code: DZE
• UDI-Device Identifier: 00844868005001
• UDI-Public: (01)00844868005001(17)230108(10)2017121350
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K063341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2021

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: 01/08/2023
• Device Model Number: IFNT410
• Device Catalogue Number: IFNT410
• Device Lot Number: 2017121350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 07/23/2021
• Supplement Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2018
• 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: 32 YR
• Patient Sex: Male