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

Model Number	T3ST413
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	02/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Doctor reported implant collar fracture #24, removal of the crown, removal of the implant and immediate replacement.Symptoms: pain, infection and mobility.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient weight unknown / not provided.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Implant date was updated to unknown.H3 other text : product not returned.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Zimvie did not receive one (1) t3st413, (t3 pro non-platform switched tapered implant 4mm (d) x 13mm (l)) 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 2022101312.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 2022101312 for similar events and no other complaint was identified.Review completed utilizing keywords: fracture implant & infection.Based on the investigation and risk management file review, the most likely root cause determined from the investigation are patient factors, clinician places implant in a patient with poor oral hygiene or parafunctional habits incompatible with long-term osseointegration of implant, bacterial infection.Therefore, based on the available information, device malfunction for the implant (t3st413) and the reported events were non-verifiable with the information provided.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were 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.

• Brand Name: T3¿ PRO NON-PLATFORM SWITCHED TAPERED IMPLANT 4MM (D) X 13MM (L)
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 16559826
• Report Number: 0002023141-2023-00831
• Device Sequence Number: 20208046
• Product Code: DZE
• UDI-Device Identifier: 00844868046936
• UDI-Public: (01)00844868046936(17)271109(10)2022101312
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K213672
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/13/2023

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: Other
• Device Model Number: T3ST413
• Device Catalogue Number: T3ST413
• Device Lot Number: 2022101312
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/20/2023
• 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: 02/20/2023
• Supplement Date Received by Manufacturer: 05/10/2023; 05/10/2023; 05/10/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 05/24/2023; 11/14/2023; 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2022
• 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: 65 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic