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

Catalog Number	TSVH11
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that two components fractured during clinical use.The abutment broke off, leaving the screw inside the implant, and the platform of the implant fractured.Tooth site 29.A new implant will be placed after healing.This report refers to fractured implant.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight: unknown / not provided.D10: concomitant medical products: unknown abutment, lot: unknown.G4: premarket identification pma/510(k) #: k013227.

• Brand Name: IMPL TAPERED SCR-V HA 3.7 MM 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: 50784581
• Report Number: 0001038806-2026-04803
• Device Sequence Number: 21461489
• Product Code: DZE
• UDI-Device Identifier: 00889024019577
• UDI-Public: (01)00889024019577(17)240402(10)1223628
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K061410
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/02/2024
• Device Catalogue Number: TSVH11
• Device Lot Number: 1223628
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Dental Abutment See H11 Narrative.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female