MAUDE Adverse Event Report: SOADCO, S.L. VEGA® NV IMPLANT Ø3.5 X 10MM; DENTAL IMPLANT

Model Number	18 35 10
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	05/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant loss is caused by the distribution of the masticatory load on the implant.The client is informed about the cause of implant rupture.
Event or Problem Description
At the date of preparation of the report it has not been possible to have the dental implant available for technical analysis and, in addition, the manufacturer of the prosthesis is unknown, so it is not possible to make a history of the material used.The data available to date are those recorded in incident (b)(4) of the same dr.With a similar implant (18 35 12 lot 26772-1124) and the data recorded in the quality report where it is specified that the patient is a bruxist.As has been reflected in this incident, if the seating of the prosthesis does not present the fit tolerances at the implant-prosthesis interface established by klockner® implant sytem, micro-movements are generated between both surfaces that will indirectly induce a localized overload on the implant with each mastication.This overload will generate a friction at the implant-prosthesis interface, which will induce a defect on the implant surface.The successive masticatory loads will induce this defect to start its propagation and consequently the failure of the implant.

• Brand Name: VEGA® NV IMPLANT Ø3.5 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: 22284585
• Report Number: 3003267134-2025-00010
• Device Sequence Number: 15676674
• Product Code: DZE
• UDI-Device Identifier: 08435451606839
• UDI-Public: (01)08435451606839
• 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: 2016
• 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): 06/17/2025

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: 01/29/2021
• Device Model Number: 18 35 10
• Device Lot Number: 21022-1064
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2016
• 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: 56 YR
• Patient Sex: Male