MAUDE Adverse Event Report: ZimVie US Corp LLC IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM; Dental Implant

Catalog Number	TSVB11
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Necrosis (1971); Swelling/ Edema (4577)
Date of Event	05/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Doctor reported inflammation, supuration, edema and pain 10 days after surgery, which does not completely clear up with antibiotics and antiseptics.Doctor also indicated possible bone necrosis at both implants.There is a delay in procedure, waiting for the bone to heal.Patient has been rescheduled for new implants placement.Tooth site 32 and 36.Implants were removed.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A1: patient identifier unknown / not provided.A4: patient weight unknown / not provided.D10.Concomitant medical products.Cm3111, eztetic dental implant, 3.1mm diameter, 2.9mmd platform, 11.5mm length lot 1274412 g4: premarket identification k013227.H6: event problem codes ¿ patient code: 1994 pain, 1932 inflammation.

• Brand Name: IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM
• 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 ; +1(561)971-3230
• MDR Report Key: 50084487
• Report Number: 0001038806-2026-04042
• Device Sequence Number: 10253643
• Product Code: DZE
• UDI-Device Identifier: 00889024019515
• UDI-Public: (01)00889024019515(17)300127(10)1295393
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K061410
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 07/30/2026

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: TSVB11
• Device Lot Number: 1295393
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/13/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Dental Implant See H10 Narrative.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female