EAGLE SWIFT 183650016Recalls & reported problems
Medos International Sàrl · EAGLE/SWIFT PLUS ANTERIOR CERVICAL PLATE SYSTEM SCREW, SELF-DRILLING 4.25 x 16mm · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034095776), received between Dec 22, 2017 and Dec 22, 2017 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (6 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 16, 2026.
Most reported problems
Device problems
- Material Fragmentation6
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Consequences Or Impact To Patient6
Recent adverse event reports
The 6 most recent of 6 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 7142563 ↗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 7142505 ↗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 7142446 ↗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 7142437 ↗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 7142344 ↗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 7142315 ↗
Other APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY devices
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 6550017Medtronic Sofamor Danek, Inc. · Appliance, fixation, spinal intervertebral body131 reports
- EVEREST® Spinal System 2901-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- Mariner RDX MX1-000040Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Mariner RDX MX1-000030Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430112Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430224Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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