MAUDE Adverse Event Report: BIOMET 3I NANOTITE TM TAPERED CERTAIN PREVAIL IMPLANT 5/4 X 15MM; DENTAL IMPLANT

Model Number	NIITP5415
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Pain (1994); No Code Available (3191)
Date of Event	03/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).A summary investigation has been completed for peri-implantitis 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 these events have not identified any signals indicating potential non-conformances affecting the manufacturing and sterilization processes.Furthermore, the probability of a manufacturing or design defect that might lead to peri-implantitis occurring 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 patient was seen for an emergency exam due to complaint of pain at niitp5415 implant #27 site.Radiograph revealed peri implant radiolucency.Implant was mobile.Implant was removed and site was grafted using puros bone graft material.Inflammation is also reported.
Additional Manufacturer Narrative
This report is being submitted to relay additional information.The following sections are being reported: b4: date of this report was updated.D4: unique identifier (udi) number was updated.D10: device availability was updated.G4: date received by manufacturer was updated.G7: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H4: device manufacturer date was updated.H6: method code was updated.H10: narrative/data was updated.The reported device was received for evaluation.The reported medical condition of peri implantitis was not confirmed.Visual inspection was not performed.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.A device history record (dhr) review was completed for the reported device lot.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 event was noted as part of the dhr.A sterilization record review was completed and all sterilization activities were conducted with no nonconformities.A complaint history review was completed for the reported device lot for similar event and no other complaint was identified.A definitive root cause for the reported event could not be determined.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.
Event or Problem Description
No additional or corrected information to report.

• Brand Name: NANOTITE TM TAPERED CERTAIN PREVAIL IMPLANT 5/4 X 15MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10259786
• Report Number: 0001038806-2020-00966
• Device Sequence Number: 11315772
• Product Code: DZE
• UDI-Device Identifier: 00844868011002
• UDI-Public: (01)00844868011002(17)190728(10)2014070790(241)NIITP5415
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K063341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2020

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: 07/28/2019
• Device Model Number: NIITP5415
• Device Catalogue Number: NIITP5415
• Device Lot Number: 2014070790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 08/04/2020
• 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: 58 YR
• Patient Weight: 108