SKYLINE 186862018SRecalls & reported problems
Medos International Sàrl · SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING SCREW 4.0 x 18mm · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034412863), received between Jul 27, 2022 and Jul 27, 2022 — 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 16, 2026.
Most reported problems
Device problems
- Migration1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Unspecified Tissue Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2022Migration; Migration
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT HAD A C56 ACDF ON (B)(6) 2022 USING SKYLINE AND VG2 ALLOGRAFT. POST OPERATIVELY THE PATIENT FELL DOWN THE STAIRS DISRUPTING THE IMPLANTS WHICH RESULTED IN THE LEFT C6 SCREW MIGRATING ANTERIORLY FROM THE PLATE. A REVISION SURGERY WAS COMPLETED TO REPLACE THE PLATE AND SCREWS. THE PATIENT REQUIRED A REVISION SURGERY DUE TO THE MIGRATION OF THE SCREW ANTERIORLY. THERE WAS A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT BECAUSE A REVISION SURGERY WAS DONE DUE TO THE MIGRATION OF THE SCREW ANTERIORLY. THERE IS NO FURTHER INFORMATION. THIS REPORT IS FOR ONE (1) SKY CONST S-T SCW 18MM TI. THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Tissue Injury
MAUDE report 15113571 ↗
Other Appliance, fixation, spinal intervertebral body devices
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- 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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