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Valeo Spacer System B (REF 11.009.1605)Recalls & reported problems

SINTX Technologies, Inc. · VALEO C 16x12mm x 5mm · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M555110091605), received between Feb 26, 2019 and Feb 26, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Unexpected Therapeutic Results” (1 report).

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

  • Unexpected Therapeutic Results1

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.

  • InjuryFeb 26, 2019Unexpected Therapeutic Results

    SURGEON REPORTED THAT HE HAD TO REMOVE THE VALEO C IMPLANT DUE TO NON-UNION. A REVISION SURGERY WAS PERFORMED.

    Patient problems: Patient Problem/Medical Problem

    MAUDE report 8370429 ↗

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