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SILC 1116.0155Recalls & reported problems

Globus Medical, Inc. · SILC 5.5mm Inline Clamp · Class 2

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 00889095029208), received between Feb 17, 2021 and Feb 17, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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

  • Material Separation1
  • Positioning Failure1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • MalfunctionFeb 17, 2021Positioning Failure; Material Separation

    IT WAS REPORTED THAT A REVISION SURGERY WAS DONE DUE TO CLAMPS THAT PULLED OFF THE ROD POST-OPERATIVELY. DURING THE REVISION THE REPLACEMENT CLAMPS WOULD NOT STAY ON THE ROD.

    Patient problems: Insufficient Information

    MAUDE report 11340490 ↗

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