MAUDE Adverse Event Report: SOADCO S.L. VEGA® RV IMPLANT Ø4.0 X 14MM; DENTAL IMPLANT

Model Number	184014
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Difficulty Chewing (4522)
Date of Event	03/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Mechanical failure due to implant fatigue caused by overload, exacerbated by crestal bone loss, is also evident.It is difficult to speculate on the cause, as no information is available on the morphology of the restored crown, although it can be confirmed that the implant is located in an area subject to high mechanical stress.Fracture of this type of device is a possible but unlikely mechanical complication, with a relatively low incidence when the instructions for use are followed (equal or less than 1% according to the values reported in the clinical evaluation of klockner® devices).However, the combination of all the factors mentioned in the technical causes increases the probability of its occurrence.
Event or Problem Description
The customer reports the breakage of a vega rv implant in a patient.They provide the corresponding quality report and x-rays of the implant placed without the prostheses.

• Brand Name: VEGA® RV IMPLANT Ø4.0 X 14MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): SOADCO S.L.; av. del pessebre, 76.82 baixos; escaldes engordany, andorra AD700 ; AN AD700
• Manufacturer (Section G): SOADCO S.L.; av. del pessebre, 76.82 baixos; escaldes engordany, AD700 ; AN AD700
• Manufacturer Contact: maria mitjaneta ; av. del pessebre, 76.82 baixos; escaldes engordany, AD700 ; AN AD700
• MDR Report Key: 24545620
• Report Number: 3003267134-2026-00002
• Device Sequence Number: 9239822
• Product Code: DZE
• UDI-Device Identifier: 08435451633231
• UDI-Public: 08435451633231
• 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: 2022
• Device Explanted Year: 2026
• 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): 03/09/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 184014
• Device Lot Number: 58278-1792
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NONE
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Unknown