MAUDE Adverse Event Report: SOADCO S.L. VEGA® RV IMPLANT Ø4.0 X 10MM; DENTAL IMPLANT

Model Number	18 40 10
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	05/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The loss of fit during seating between the prosthesis and the implant does not distribute the masticatory load evenly and, consequently, increases the likelihood of generating defects in the implant that will lead to its failure due to material fatigue.Therefore, this loss of fit has a direct impact on the distribution of the masticatory load on the implant and, consequently, on its mechanical and fatigue resistance.
Event or Problem Description
An broken implant is received at soadco s.L.Facilities where the manufacturer and the state of the prosthesis placed is unknown (cause: breakage of the implant in the patient).This implant presents a plastic deformation of the material.Previously a claim has been received for this same implant model and manufacturing lot.This incidence is directly related to the loss of adjustment between the prosthesis and the implant.

• Brand Name: VEGA® RV IMPLANT Ø4.0 X 10MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): SOADCO S.L.; av. de pessebre, 76-82; escaldes-engordany, AD700 ; AN AD700
• Manufacturer (Section G): SOADCO S.L.; av. de pessebre, 76-82; escaldes-engordany, AD700 ; AN AD700
• Manufacturer Contact: maria mitjaneta ; av. de pessebre, 76-82; escaldes-engordany, AD700 ; SP AD700
• MDR Report Key: 22284584
• Report Number: 3003267134-2025-00009
• Device Sequence Number: 15676673
• Product Code: DZE
• UDI-Device Identifier: 08435451606877
• UDI-Public: (01)08435451606877
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K153098
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 06/18/2025

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: Health Professional
• Device Expiration Date: 09/29/2021
• Device Model Number: 18 40 10
• Device Lot Number: 26526-1122
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2016
• 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: 52 YR
• Patient Sex: Unknown