MAUDE Adverse Event Report: ZIMVIE US CORP LLC T3® PRO TAPERED IMPLANT 5/4MM (D) X 10MM (L); DENTAL IMPLANT

Catalog Number	T3PT5410
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had an indirect sinus at the implant placement procedure at tooth site #14.After the surgery, the patient developed a sinus infection.The patient was not called back because they were already on antibiotics.It was noted that there was not drainage at the site.The patient returned for a three-month examination.The patient had failed to contact the customer about the sinus infection that she had post-operation.The patient complained that the implant became loose and uncomfortable.The patient arrived to an examination on (b)(6) 2026 with the implant in their hand, which had came out at their home while eating banana nut bread.This occurred the day before the appointment.The site was left to heal for a month, after which, a replacement procedure was anticipated.The customer also expressed that there was no sinus preformation noted and that it was unknown what caused the implant failure.Symptoms as a result of the event: sinus infection.
Additional Manufacturer Narrative
Zimvie complaint number: (b)(4).A4: weight unknown / not provided.B3: date of event unknown / not provided.A summary investigation has been completed for infection events identifying that a definitive root cause cannot be identified due to the wide range of external (non-design/ non-manufacturing related) factors potentially impacting the sterility of the implant and its environment.Should additional information be received which indicates that the device may have caused or contributed to the infection event, an additional report will be submitted.

• Brand Name: T3® PRO TAPERED IMPLANT 5/4MM (D) X 10MM (L)
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMVIE US CORP LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMVIE US CORP LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: mark mashburn ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 24899189
• Report Number: 0001038806-2026-02083
• Device Sequence Number: 9690356
• Product Code: DZE
• UDI-Device Identifier: 00844868046769
• UDI-Public: (01)00844868046769(17)300629(10)2120035158
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 04/16/2026

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 Catalogue Number: T3PT5410
• Device Lot Number: 2120035158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2025
• 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: 82 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic