MAUDE Adverse Event Report: BIOMET 3I 3I T3 EX HEX TAPERED IMPLANT 4 X 13MM; DENTAL IMPLANT

Model Number	BOET413
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Weight unknown / not provided.Email address unknown / not provided.
Event or Problem Description
Based on available information, there are no signs of a device malfunction.The event description is not defined.However, the implant was placed (b)(6) 2013 and was explanted on (b)(6) 2020.This event is reportable as a serious injury due to the surgical / medical intervention required to preclude / resolve issues associated with the implant.
Additional Manufacturer Narrative
Zimmerbiomet complaint number: (b)(4).One 3i t3® ex hex tapered implant 4 x 13mm (boet413) was returned for investigation attached to an unknown removal tool.Visual evaluation of the as returned product identified moderate signs of wear and debris attachment about the implant threads.Product matched print specification where measured.No pre-existing conditions were noted on the per.The reported product was located on tooth # 13 (fdi) and used for approximately 7 years.The reported event could not be recreated due to the nature of the dental device and without further information regarding the event.Dhr review was completed for the subject lot number 2016080682.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 was performed for the reported lot number (2016080682) for similar event and no other complaint was identified.July post market trending was reviewed and there were no actionable events or corrective actions for the reported product (boet413).Therefore, based on the available information, device malfunction could not be verified and no reported event given.Therefore the event is concluded to be non-verifiable.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: 3I T3 EX HEX TAPERED IMPLANT 4 X 13MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10224315
• Report Number: 0001038806-2020-00917
• Device Sequence Number: 16272176
• Product Code: DZE
• UDI-Device Identifier: 00844868033271
• UDI-Public: (01)00844868033271(17)210907(10)2016080682(241)BOET413
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K133049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2020

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: Health Professional
• Device Expiration Date: 09/07/2021
• Device Model Number: BOET413
• Device Catalogue Number: BOET413
• Device Lot Number: 2016080682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 07/02/2020
• Supplement Report FDA Received Date: 09/29/2020
• 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