MAUDE Adverse Event Report: SOADCO, S.L. VEGA RV Ø4.0 X 08MM IMPLANT; DENTAL IMPLANT

Model Number	18 40 08
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	09/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After technical analysis of the incident, it was concluded that:the manipulation of the prosthesis seating area resulted in a loss of tolerance in the fit of the implant-prosthesis interface.This resulted in an uneven distribution of masticatory loads to the implant, and consequently, increased the likelihood of implant defects that could lead to implant failure due to material fatigue.
Event or Problem Description
Klockner s.A.Informs soadco, s.L.That a doctor informed them of a broken dental implant in a multiple prosthesis.

• Brand Name: VEGA RV Ø4.0 X 08MM IMPLANT
• 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 ; AN AD700
• MDR Report Key: 22284593
• Report Number: 3003267134-2025-00011
• Device Sequence Number: 8893325
• Product Code: DZE
• UDI-Device Identifier: 08435451633187
• UDI-Public: (01)08435451633187
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K153098
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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: 12/07/2021
• Device Model Number: 18 40 08
• Device Lot Number: 28441-1143
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (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 Sex: Unknown