MAUDE Adverse Event Report: BIOMET 3I T3¿ PRO NON-PLATFORM SWITCHED TAPERED IMPLANT 4MM (D) X 13MM (L); DENTAL IMPLANT

Catalog Number	T3ST413
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	07/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint (b)(4).Initial reporter¿s email address is not provided / unknown.
Event or Problem Description
It was reported that the implant at tooth site (b)(6) was removed due to discomfort in the area.Patient reported pain in the area of implant.Implant was removed, granulation tissue present in osteotomy area, debrided area.The site was grafted with allograft together with original implant placement.
Additional Manufacturer Narrative
This report is being submitted to report additional information.Zimvie did not receive one implant for evaluation.Visual inspection could not be performed.The investigation has been performed based on the available information using the item number, device history record (dhr) review, and risk management file (rmf).Dhr review was completed for the subject lot number.No deviations or non-conformance's, which could have caused or contributed to the reported event, were noted as part of the dhr.Sterilization record was reviewed and verified to have passed all sterilization activities with no issues or nonconformities identified.Complaint history review was performed for the reported lot number for similar events and no other complaint was identified.A definitive root cause could not be determined.Therefore, based on the available information, a device malfunction could not be verified.Without device receipt, the reported event is non-verifiable.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 additional or corrected information to report.
Additional Manufacturer Narrative
This report is being submitted to report corrected and additional information.The product was now received by the manufacturer.The product investigation was re opened and completed again.The following sections are being reported: d9: device availability.H2: if follow-up, what type.H3: device evaluated by manufacturer.H6: type of investigation.H10: additional narratives/data.Zimvie received one implant for evaluation.Visual evaluation of the as returned device identified the implant with signs of use.Implant was returned with no damage that would cause or contribute to the reported event.Some markings were identified on the implant likely due to the removal process.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 cause determined from the investigation is inadequate treatment planning.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: T3¿ PRO NON-PLATFORM SWITCHED TAPERED IMPLANT 4MM (D) X 13MM (L)
• 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 ; 5617766700
• MDR Report Key: 16617584
• Report Number: 0001038806-2023-00592
• Device Sequence Number: 7305508
• Product Code: DZE
• UDI-Device Identifier: 00844868046936
• UDI-Public: (01)00844868046936(17)270428(10)2022030715
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K213672
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2024

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: T3ST413
• Device Lot Number: 2022030715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2023
• Supplement Date Received by Manufacturer: 03/13/2023; Not provided
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 08/28/2023; 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic