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	03/14/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer comments in the qr (quality report) that he has proceeded to its extraction of the dental implant dated (b)(6) 2019 (2 years after its placement) - (b)(6) 2017) after the rupture of this implant.In the same qr the client comments that is a bone type d1 and the gingiva state is lack of inflamation.Patient (66-year-old female).
Additional Manufacturer Narrative
Manipulation of the prosthesis seating results in a loss of fit tolerance at the implant-prosthesis interface.This misalignment increases the micromovement between the two surfaces, which induces localized overload on the implant each time mastication occurs.This overload generates localized friction at the implant-prosthesis interface, which can ultimately generate a fatigue failure in the dental implant.

• Brand Name: VEGA RV IMPLANT Ø4.0 X 10MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): SOADCO, S.L.; av. del pessebre, 76-82; escaldes-engordany, AD700 ; AN AD700
• Manufacturer (Section G): SOADCO, S.L.; av. del pessebre, 76-82; escaldes-engordany, AD700 ; AN AD700
• Manufacturer Contact: maria mitjaneta ; av. del pessebre, 76-82; escaldes-engordany, AD700 ; AN AD700
• MDR Report Key: 22284577
• Report Number: 3003267134-2025-00007
• Device Sequence Number: 12984917
• 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: 11/30/2021
• Device Model Number: 18 40 10
• Device Lot Number: 28279-1141
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2016
• 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: 66 YR
• Patient Sex: Female