MAUDE Adverse Event Report: BIOMET 3I NANOTITE TM TAPERED CERTAIN PREVAIL IMPLANT 6/5 X 15MM; DENTAL IMPLANT

Model Number	NIITP6515
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); No Code Available (3191)
Date of Event	10/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Patient weight is not provided / unknown.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
Doctor reports that the niitp6515 implant was removed due to bone loss.Pain and inflammation are reported as symptoms.Tooth location # 2.Sinus lift had been performed prior to placement in 2010.Graft used was autogenous and xenograft.
Additional Manufacturer Narrative
This report is being submitted to relay corrected information.Lot number was manufactured prior to udi number requirements.Therefore, udi number was corrected to unknown.The following sections are being reported: b4: date of this report was updated.D4: the udi number is not known.G4: date received by manufacturer was updated.G7: type of report was updated.H2: type of follow up was updated.H10: narrative/data was updated.
Event or Problem Description
No additional or corrected information to report.

• Brand Name: NANOTITE TM TAPERED CERTAIN PREVAIL IMPLANT 6/5 X 15MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10876977
• Report Number: 0001038806-2020-01865
• Device Sequence Number: 14281711
• Product Code: DZE
• UDI-Device Identifier: 00844868011057
• UDI-Public: (01)00844868011057(17)180326(10)2013030063(241)NIITP6515
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K063341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2021

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: 03/26/2018
• Device Model Number: NIITP6515
• Device Catalogue Number: NIITP6515
• Device Lot Number: 2013030063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 02/05/2021
• 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: 72 YR