MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® TAPERED IMPLANT 3.25 X 10MM; DENTAL IMPLANT

Model Number	NT3210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Date of Event	07/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the implant was removed due to peri-implantitis.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One osseotite® tapered implant 3.25 x 10mm (nt3210) was returned for investigation.Visual inspection of the as returned product identified signs of use, dried bone, wear along the external hex/collar, damaged threads from removal but no apparent malfunction.Functional testing to recreate the reported event could not be performed due to the nature of the devices & events.The reported devices were measured with calipers and were each verified to match their respective specifications.No pre-existing conditions were noted on the per, the patient had moderate (type ii) bone density.The reported devices were located on unknown teeth and were used for 2 years 6 months.The customer did not provide pictures or x-ray images.Device history record (dhr) reviews were completed for the subject lot number.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformance, which could have caused or contributed to the reported events, were noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.
Event or Problem Description
No further event information is avaliable at the time of this report.

• Brand Name: OSSEOTITE® TAPERED IMPLANT 3.25 X 10MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9400645
• Report Number: 0001038806-2019-01505
• Device Sequence Number: 2210018
• Product Code: DZE
• UDI-Device Identifier: 00844868011965
• UDI-Public: (01)00844868011965(17)200109(10)2014120820(241)NT3210
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K063286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2020

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: 01/09/2020
• Device Model Number: NT3210
• Device Catalogue Number: NT3210
• Device Lot Number: 2014120820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/04/2019
• Supplement Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 01/31/2020
• 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: 75 YR