MAUDE Adverse Event Report: BIOMET 3I 3I T3 WITH DCD TAPERED IMPLANT 4/3 X 8.5MM; DENTAL IMPLANT

Catalog Number	BNPT4385
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
The implant was removed due to an unknown reason.
Additional Manufacturer Narrative
Zimvie complaint (b)(4).
Additional Manufacturer Narrative
This report is being submitted to report additional information.Customer confirmed the tooth site number, placement and removal dates.The following sections are being reported: b5: describe event or problem d6a: if implanted, give date.D6b: if explanted, give date.H2: if follow-up, what type.H10: additional narratives/data.
Event or Problem Description
It was confirmed by customer that the tooth site is #9.
Event or Problem Description
No additional or corrected information to report.
Additional Manufacturer Narrative
This report is being submitted to report additional information.One implant was returned for investigation.Visual/physical evaluation of the as returned product identified signs of use (bone residue around external threads) but no apparent signs of malfunction.Dimensional analysis was performed, and device was determined to be within specs.Dhr review was completed for the subject lot number.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number for similar events and no other complaint was identified.The customer did not submit images for the reported event.Based on the investigation, the most likely root causes could not be determined.Device malfunction has not occurred.Additionally, the reported event could not be verified since the exact details of event were unknown/unverifiable.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.

• Brand Name: 3I T3 WITH DCD TAPERED IMPLANT 4/3 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 ; 5619713230
• MDR Report Key: 18049619
• Report Number: 0001038806-2023-02080
• Device Sequence Number: 15517555
• Product Code: DZE
• UDI-Device Identifier: 00844868028352
• UDI-Public: (01)00844868028352(17)260125(10)2021010161
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K122300
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/30/2024

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: 01/24/2026
• Device Catalogue Number: BNPT4385
• Device Lot Number: 2021010161
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 12/20/2023; 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2021
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic