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EAGLE SWIFT 183651016Recalls & reported problems

Medos International Sàrl · EAGLE/SWIFT PLUS ANTERIOR CERVICAL PLATE SYSTEM SCREW, SELF-TAPPING 4.4 x 16mm · Class 2

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

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034095882), received between Dec 22, 2017 and Dec 22, 2017 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (3 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 18, 2026.

Most reported problems

Device problems

  • Material Fragmentation3

Patient problems

  • No Consequences Or Impact To Patient3
  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 22, 2017Material Fragmentation; Material Fragmentation

    THE SURGEON WAS RE-POSITIONING A PLATE. HE HAD A DIFFICULT TIME REMOUNTING THE SCREWS AND BROKE OR STRIPPED SOME OF THE DRIVERS. UPON INSPECTION SOME OF THE THREADS ON THE SCREWS WERE MESSED UP SO THE SURGEON DID NOT FEEL COMFORTABLE PUTTING THOSE BACK IN AND THAT THEY WOULD STILL BE BLOCKED BY THE CLOCKING RING.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

    MAUDE report 7142360 ↗
  • MalfunctionDec 22, 2017Material Fragmentation; Material Fragmentation

    THE SURGEON WAS RE-POSITIONING A PLATE. HE HAD A DIFFICULT TIME REMOUNTING THE SCREWS AND BROKE OR STRIPPED SOME OF THE DRIVERS. UPON INSPECTION SOME OF THE THREADS ON THE SCREWS WERE MESSED UP SO THE SURGEON DID NOT FEEL COMFORTABLE PUTTING THOSE BACK IN AND THAT THEY WOULD STILL BE BLOCKED BY THE CLOCKING RING.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7141882 ↗
  • MalfunctionDec 22, 2017Material Fragmentation; Material Fragmentation

    THE SURGEON WAS RE-POSITIONING A PLATE. HE HAD A DIFFICULT TIME REMOUNTING THE SCREWS AND BROKE OR STRIPPED SOME OF THE DRIVERS. UPON INSPECTION SOME OF THE THREADS ON THE SCREWS WERE MESSED UP SO THE SURGEON DID NOT FEEL COMFORTABLE PUTTING THOSE BACK IN AND THAT THEY WOULD STILL BE BLOCKED BY THE CLOCKING RING.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

    MAUDE report 7141846 ↗

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Sources and updates

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