MAUDE Adverse Event Report: BIOMET 3I 3I T3 WITH DCD TAPERED IMPLANT 5/4 X 15MM; DENTAL IMPLANT

Catalog Number	BNPT5415
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
It was reported that patient presented with pain (unbearable) requested to have implant removed.Tooth #4.Symptoms as a result of the event: pain.
Additional Manufacturer Narrative
One 3i t3 with dcd tapered implant, (bnpt5415) was returned for evaluation.Visual/physical evaluation of the as returned product identified signs of use, but no apparent signs of malfunction.Cal05593632 (due: may 30, 2024).Dhr and sterilization records (op0210) review was completed for the subject lot number 2022100256.No deviations or non-conformance's, 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 2022100256 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental: medical: pain.¿ the customer did not submit images for the reported event.Review of appropriate documentation: documents reviewed: biomet 3i dental implant ifu (p-iis086gi), rev j - 8/1/2022.Information identified: potential adverse events.Per the applicable ifu, ¿potential adverse events associated with the use of dental implants may include failure to integrate, loss of integration, dehiscence requiring bone grafting, perforation of the maxillary sinus, inferior border, lingual plate, labial plate, inferior alveolar canal, or gingiva, infection as reported by abscess, fistula, suppuration, inflammation, or radiolucency, persistent pain¿.Based on the investigation and risk management file review, the most likely root causes determined from the investigation were incorrect techniques use during placement.Therefore, based on the available information, device malfunction has not occurred.Additionally, the reported event could not be verified as 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.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: 3I T3 WITH DCD TAPERED IMPLANT 5/4 X 15MM
• 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: 17732988
• Report Number: 0001038806-2023-01711
• Device Sequence Number: 20468835
• Product Code: DZE
• UDI-Device Identifier: 00844868029496
• UDI-Public: (01)00844868029496(17)271020(10)2022100256
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2024

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: Other
• Device Catalogue Number: BNPT5415
• Device Lot Number: 2022100256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2022
• 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: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic