KLOCKNER 18 40 10Recalls & reported problems
Soadco, S.L. · VEGA RV Ø4.0 X 10MM IMPLANT · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08435451606877), received between Jun 18, 2025 and Jun 18, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture2
Patient problems
- Implant Pain2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 18, 2025Fracture; Fracture
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.
Patient problems: Implant Pain
MAUDE report 22284584 ↗InjuryJun 18, 2025Fracture; Fracture
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).
Patient problems: Implant Pain
MAUDE report 22284577 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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