MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® TAPERED IMPLANT 3.25 X 10MM; DENTAL IMPLANT

Model Number	NT3210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Date of Event	01/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).
Event or Problem Description
It was reported that the implant was removed due to perimplantitis.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).An osseotite® tapered implant 3.25 x 10mm (item nt3210) was received for investigation.Visual inspection of the as returned product identified evidence of wear from use that was significant enough so as to prevent reliable measurement of the product.There were noticeable gouges around the external threads and the collar, likely from the removal process.Also, the hex and the drive feature had presence of debris (dried blood).No pre-existing conditions were noted on the product experience report that could contribute to the event.Pictures or x-ray images were not provided to evaluate of periimplantitis.Device history record (dhr) review was completed for the subject lot number (2014120820).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 events was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.No definitive root cause was identified.Probable causes as per risk management file are listed above in the risk assessment summary.However, based on the investigation and risk review, the most likely cause for the reported event is external patient factors.

• Brand Name: OSSEOTITE® TAPERED IMPLANT 3.25 X 10MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9400088
• Report Number: 0001038806-2019-01504
• Device Sequence Number: 19489671
• Product Code: DZE
• UDI-Device Identifier: 00844868011965
• UDI-Public: (01)00844868011965(17)200109(10)2014120820(241)NT3210
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K063286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2020

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: 01/09/2020
• Device Model Number: NT3210
• Device Catalogue Number: NT3210
• Device Lot Number: 2014120820
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/04/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/04/2019
• Supplement Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 02/05/2020
• 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: 49 YR