MAUDE Adverse Event Report: BIOMET 3I DO NOT USE-NANOTITE TM CERTAIN IMPLANT 5 X 13MM; DENTAL IMPLANT

Model Number	NIOSS513
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Weight 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.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
It was reported that the implant at tooth site #14 was removed due to bone loss around implant.
Additional Manufacturer Narrative
This report is being submitted to relay corrected data and additional information.Associated lot #943288 was manufactured prior to 24-sep-2015, as a result, a udi number is not required.The following sections are being reported: b4: date of this report was updated.D4: udi number was removed.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H6: component code was added: 4755.H10: narrative/data was updated.
Event or Problem Description
No additional event information at the time of this report.

• Brand Name: DO NOT USE-NANOTITE TM CERTAIN IMPLANT 5 X 13MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11119212
• Report Number: 0001038806-2021-00019
• Device Sequence Number: 19735157
• Product Code: DZE
• UDI-Device Identifier: 00844868011415
• UDI-Public: (01)00844868011415(17)150201(10)943288(241)NIOSS513
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K051461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2021

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: Health Professional
• Device Expiration Date: 02/01/2015
• Device Model Number: NIOSS513
• Device Catalogue Number: NIOSS513
• Device Lot Number: 943288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 03/19/2021
• 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: 64 YR