MAUDE Adverse Event Report: BIOMET 3I 3I T3 WITH DCD TAPERED IMPLANT 6/5 X 13MM; DENTAL IMPLANT

Catalog Number	BNPT6513
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Paresthesia (4421)
Date of Event	10/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint (b)(4).
Event or Problem Description
It was reported that the patient reported paresthesia to her left lip/chin, status post placement at #18, immediate implant.The inferior alveolar nerve was not seen or palpated during surgery, nor was there any unusual bleeding.Post-op sensation testing revealed a deficit in sensation one week later.The implant was removed.
Additional Manufacturer Narrative
This report is being submitted to report additional information.Zimvie received one implant for evaluation.Visual evaluation of the as returned device identified the implant with signs of use, and markings from removal.No damage identified or signs of malfunction that would contribute to the reported event.Measurements match drawing.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.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.Based on the investigation and risk management file review, the most likely root causes determined from the investigation are improper techniques used and patient factors.Therefore, based on the available information, a device malfunction did not occur.The reported event was non-verifiable with all the available information.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.
Event or Problem Description
No additional or corrected information to report.

• Brand Name: 3I T3 WITH DCD TAPERED IMPLANT 6/5 X 13MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMVIE; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 18129761
• Report Number: 0001038806-2023-02185
• Device Sequence Number: 6349092
• Product Code: DZE
• UDI-Device Identifier: 00844868029526
• UDI-Public: (01)00844868029526(17)230215(10)2018020064
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2024

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: 02/14/2023
• Device Catalogue Number: BNPT6513
• Device Lot Number: 2018020064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• 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
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2018
• 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 Age: 43 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic