MAUDE Adverse Event Report: BIOMET 3I 3I T3 WITH DCD TAPERED IMPLANT 6/5 X 10MM; DENTAL IMPLANT

Model Number	BNPT6510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint: (b)(4).Patient's weight is unknown.Device not returned.
Event or Problem Description
It was reported that the patient was experiencing pain since placement.Implant was removed as it was determined to have been rejected by the patient.Patient will return for a new implant.Tooth #30.
Additional Manufacturer Narrative
Product evaluation: the 3i t3® with dcd® tapered implant 6/5 x 10mm (bnpt6510) was not returned.Since product has not been returned, visual/functional evaluation could not be performed.The investigation has been performed based on the available information.No pre-existing conditions were indicated.The reported product was located on tooth # 30 (universal) and used for approximately 22 days.The reported event could not be recreated due to the nature of the dental device and event (medical condition).Dhr review: dhr review was completed for the subject lot number 2019071505.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 was 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 (2019071505) for similar event and no other complaint was identified.Post market trend review: september post market trending was reviewed and there were no actionable events or corrective actions for the reported event (customer pain) or product (bnpt6510).The location is: therefore, based on the available information, device malfunction could not be verified and the reported event was non-verifiable.
Event or Problem Description
There is no update to the original description that was provided.

• Brand Name: 3I T3 WITH DCD TAPERED IMPLANT 6/5 X 10MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10514776
• Report Number: 0001038806-2020-01344
• Device Sequence Number: 19444190
• Product Code: DZE
• UDI-Device Identifier: 00844868029502
• UDI-Public: (01)00844868029502(17)241007(10)2019071505(241)BNPT6510
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K122300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2020

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: 10/07/2024
• Device Model Number: BNPT6510
• Device Catalogue Number: BNPT6510
• Device Lot Number: 2019071505
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 11/23/2020
• 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: 39 YR