MAUDE Adverse Event Report: BIOMET 3I 3I T3 EX HEX PARALLEL WALLED IMPLANT 4 X 8.5MM; DENTAL IMPLANT

Model Number	BOES485
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.Email address unknown / not provided.
Event or Problem Description
It was reported implant removed due to fracture and infection.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One (1) 3i t3® ex hex parallel walled implant 4 x 8.5mm (boes485) was returned for investigation.Visual evaluation of the as returned product did not identify a fractured implant.Instead, the implant showed signs of use with human bone attached to the implant body.The non-reported abutment was attached to the top portion of the implant and there was what appears to be dried blood around the device.Device history record (dhr) review was completed for the subject lot number 2018010747.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 (2018010747) for similar events and one (1) other complaint was identified, for infection.Investigation has identified that the most likely probable causes are related to patient biological factors/condition and surgical technique.Therefore, based on the available information, device malfunction has not occurred and the reported implant fracture was unconfirmed as physical evaluation did not identify the fractured implant.Also, the reported medical event (infection) could not be verified.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: 3I T3 EX HEX PARALLEL WALLED IMPLANT 4 X 8.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10470497
• Report Number: 0001038806-2020-01253
• Device Sequence Number: 13989993
• Product Code: DZE
• UDI-Device Identifier: 00844868032502
• UDI-Public: (01)00844868032502(17)230126(10)2018010747(241)BOES485
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/26/2023
• Device Model Number: BOES485
• Device Catalogue Number: BOES485
• Device Lot Number: 2018010747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/07/2020
• Supplement Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 11/30/2020
• 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