MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® TAPERED CERTAIN® IMPLANT 6 X 8.5MM; DENTAL IMPLANT

Model Number	XIFNT685
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	04/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that the implant was removed due to becoming fractured and bone loss.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following sections have been updated: b4: date of this report.B5: describe event or problem.G3: date received by the manufacturer.H1: type of report, follow-up number.H2: follow up type.H3: device evaluated by manufacturer: change ¿no' to 'yes'.H6: evaluation codes.H10: additional narrative.One implant was returned for investigation.Visual evaluation of the as returned implant revealed that there were signs of use and wear.The abutment was attached to the implant and could not be removed.The implant was not fracture.Zimvie is not responsible for any damage caused by the clinician's removal of the device.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.A pre-existing condition noted on the product experience report (per) was bruxism.The reported device was in tooth location 16 (fdi) and was used for approximately 1 years, 4 months.X-ray & picture evaluation: the customer did not provide any images for the reported event.Review of appropriate documentation: documents reviewed: biomet 3i dental implant ifu (p-iis086gi) rev j ¿ july 2021 1/8/2022.Information identified: 'contraindications' 'warnings' 'precautions' 'potential adverse events' dhr review: dhr review was completed for the subject lot number 2016102052.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review: complaint history review was performed for the reported lot number 2016102052 for similar events and no other complaint was identified.Review completed utilizing keywords: 'dental : functional : fracture'.Post market trend review: october post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.No actionable items have been triggered that will affect complaint handling on our end for this month.Based on the available information, a device malfunction did not occur, and the reported event was unconfirmed.Additionally, bone loss is a patient condition and is non-verifiable with the all the available information provided.

• Brand Name: OSSEOTITE® TAPERED CERTAIN® IMPLANT 6 X 8.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 15130092
• Report Number: 0001038806-2022-01152
• Device Sequence Number: 12167102
• Product Code: DZE
• UDI-Device Identifier: 00844868022091
• UDI-Public: (01)00844868022091(17)211110(10)2016102052
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K130949
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2023

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: 11/10/2021
• Device Model Number: XIFNT685
• Device Catalogue Number: XIFNT685
• Device Lot Number: 2016102052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2022
• Supplement Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female