SKYLINE 186802028SRecalls & reported problems
Medos International Sàrl · SKYLINE ANTERIOR CERVICAL PLATE SYSTEM TWO LEVEL PLATE 28mm · Class 2 · Implant
All models of SKYLINE (39)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 10705034411958), received between Aug 26, 2022 and Aug 26, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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 16, 2026.
Most reported problems
Device problems
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED ON AN UNKNOWN DATE, THE SURGEON WAS USING SKYLINE PLATE AND SCREWS FOR ACDF. SURGEON LOCKED ALL SCREWS THEN NOTICED MOST CRANIAL SCREW ON PATIENT RIGHT SIDE WAS NOT ALL THE WAY DOWN. SURGEON UNLOCKED CAM TIGHTENER, REPOSITIONED SCREW, AND ATTEMPTED TO LOCK CAM MECHANISM AGAIN BUT CAM LOCK JUST SPUN AROUND AND WOULD NOT LOCK. SURGEON CONFIRMED SCREW ANGULATION AND POSITIONING WAS ADEQUATE. SURGEON THEN REMOVED AND REPLACED SKYLINE PLATE AND PROCEEDED TO FINISH CASE WITH NO HARM TO PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF FIFTEEN (15) MINUTES. THERE WAS NO PATIENT HARM REPORTED. THIS REPORT IS FOR ONE (1) SKY 2 LEVEL PLTE 28MM TI. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15302928 ↗
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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