MAUDE Adverse Event Report: BIOMET 3I NANOTITE TM TAPERED CERTAIN IMPLANT 5 X 11.5MM; DENTAL IMPLANT

Model Number	NINT511
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Swelling (2091); No Code Available (3191)
Date of Event	08/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Patient sex unknown / not provided.Weight unknown / not provided.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.Summary reporting.
Event or Problem Description
It was reported that the patient noticed some mobility of the crown (b)(6) 2020 at tooth location #18, x-ray taken on (b)(6) 2020 reveals a large radiolucent area around the implant.The periodontal probing exceeded 10mm on the distal, lingual and buccal sides of the implant.Patient experienced pain, swelling and palpation.Implant was removed (b)(6) 2020.Crown was fabricated by restoring dentist.
Additional Manufacturer Narrative
Section "d4: device udi number" was submitted with udi # (b)(4) in error.Associated lot # 964336 was manufactured prior to 24-sep-2015, as a result, a udi number is not required.The following sections have been updated: g7: checked "follow-up".
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: NANOTITE TM TAPERED CERTAIN IMPLANT 5 X 11.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10770667
• Report Number: 0001038806-2020-01722
• Device Sequence Number: 1902375
• Product Code: DZE
• UDI-Device Identifier: 00844868011187
• UDI-Public: (01)00844868011187(17)150721(10)964336(241)NINT511
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K063341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2021

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: 07/21/2015
• Device Model Number: NINT511
• Device Catalogue Number: NINT511
• Device Lot Number: 964336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 01/27/2021
• 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: 78 YR