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Valeo Spacer System B (REF 11.009.1007)Recalls & reported problems

SINTX Technologies, Inc. · Valeo C 16x12, 0°, 7mm with Alternate Texturing · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M555110091007), received between Feb 25, 2019 and Feb 25, 2019 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Patient Problem/Medical Problem1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PATIENT HAD THE INITIAL SURGERY ON (B)(6) 2014 AND A VALEO C WAS IMPLANTED. IN 2017, FOLLOW-UP IMAGING SHOWED SOME SPACE BETWEEN THE IMPLANT AND VERTEBRAE. THE VALEO C IMPLANT WAS REMOVED ON (B)(6) 2017 BY THE SURGEON BECAUSE THE IMPLANT WAS LOOSE WHEN THE SURGEON GRABBED ONTO IT. THE SURGEON COMMUNICATED THAT THERE WAS A SOLID CORE OF BONE GROWTH THROUGH THE IMPLANT WITH SOME BONY ON GROWTH ON THE SUPERIOR AND INFERIOR SURFACES. THE SURGEON REMOVED THE VALEO C IMPLANT AND REPLACED IT WITH A VBR.

    Patient problems: Patient Problem/Medical Problem

    MAUDE report 8368647 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.