MAUDE Adverse Event Report: BIOMET 3I 3I T3® WITH DCD® NON-PLATFORM SWITCHED TAPERED IMPLANT 4 X 13MM; DENTAL IMPLANT

Model Number	BNST413
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).A summary investigation has been completed for lack of primary stability events that do not allege a deficiency with the implant and identified that the reported event is likely due to biological factors which have an adverse effect on implant stability or is related to surgical technique and insertion torque.Due to a wide range of external factors (non-design/non-manufacturing related), identifying a definitive root cause is generally not possible.Should additional information be received which indicates that the device may have caused or contributed to the event, an additional report will be submitted.
Event or Problem Description
Doctor reports that lack of primary stability was not achieved for implant bnst413 in tooth site #12.
Event or Problem Description
Doctor reports implant bnst413 was placed on (b)(6) 2019 and removed on (b)(6) 2019 due to non integration.
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).This follow up report is being submitted due to corrected information being received.The placement date of the implant was incorrectly stated to be (b)(6) 2019.The correct placement date is (b)(6) 2019.The event is updated from being reported as a serious injury to be an event not meeting the criteria of a reportable event.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: 3I T3® WITH DCD® NON-PLATFORM SWITCHED TAPERED IMPLANT 4 X 13MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9254982
• Report Number: 0001038806-2019-01268
• Device Sequence Number: 1878913
• Product Code: DZE
• UDI-Device Identifier: 00844868029168
• UDI-Public: (01)00844868029168(17)231018(10)2018092065(241)BNST413
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2019

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: 10/18/2023
• Device Model Number: BNST413
• Device Catalogue Number: BNST413
• Device Lot Number: 2018092065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 11/19/2019
• 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