MAUDE Adverse Event Report: ZIMVIE US CORP LLC T3® PRO TAPERED IMPLANT 4/3MM (D) X 11.5MM (L); DENTAL IMPLANT

Catalog Number	T3PT4311
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Osteolysis (2377)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4)/ a4: patient weight unknown / not provided.B3: date of event unknown / not provided.H6: additional h6- patient codes: 1994: pain, 4755: swelling/edema.
Event or Problem Description
It was reported that the implants at tooth site # 30 was removed due to infection & bone loss and allergic reaction.Possible allergic reaction or patient's body rejecting implants.Post-op visit 2 for zimvie biomet 3i dental implant 29 t3pt4310 tight to 50 ncm and encode healing abutment ieeha353.Patient doing well and used medications (cefdinir) as prescribed.Mild redness 31-m but no gingival swelling.Both healing abutments mobile and pain to twisting.Periapical radiograph lr and shows radiolucency all around the dental implant.Appears patient rejecting the dental implant or could have had an infection.Patient has titanium joint replacements with no problems.She knows of no metal allergies.Explained to patient dental implant needs to be removed and bone grafting of the ridge needed again.I showed patient the post-op radiograph on (b)(6) 2026 and how good the bone looked and how it has resorbed since then.Symptoms / patient impact: pain, swelling.

• Brand Name: T3® PRO TAPERED IMPLANT 4/3MM (D) X 11.5MM (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: 25484808
• Report Number: 0001038806-2026-03165
• Device Sequence Number: 9966206
• Product Code: DZE
• UDI-Device Identifier: 00844868046721
• UDI-Public: (01)00844868046721(17)291216(10)2120024970
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2026

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: T3PT4311
• Device Lot Number: 2120024970
• Was Device Available for Evaluation?: No
• 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: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2024
• 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
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic