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ACDF Stand Alone Cervical 03.18.103Recalls & reported problems

Medacta International SA · Mecta-C SA TiPEEK Cage 15x13x7x7° · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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 07630040725576), received between Mar 30, 2023 and Mar 30, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Migration” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Migration1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1

Recent adverse event reports

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

  • InjuryMar 30, 2023Migration; Migration

    AT ABOUT 11 MONTHS FROM PRIMARY SURGERY THE SURGEON REVISED THE ACDF DEVICES (C4-C5). THE PATIENT PRESENTED PSEUDOARTHROSIS, IMPLANT SUBLISDENCE, INSTABILITY AND METALLOSIS WAS OBSERVED BUT FOR THE SURGEON IT IS UNKNOWN WHICH IS THE PRINCIPAL REVISION REASON. REVISION WAS COMPLETED SUCCESSFULLY IMPLANTING COMPETITOR DEVICES. THE PRIMARY SURGERY WAS PERFORMED AS 2 LEVEL EXTENSION OF AN EXISTENT SPINAL IMPLANT (C5-C6-C7).

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 16644026 ↗

Other Intervertebral Fusion Device With Integrated Fixation, Cervical devices

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Sources and updates

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