SKYLINE 286820400Recalls & reported problems
Depuy Spine, LLC · SKYLINE ANTERIOR CERVICAL PLATE SYSTEM SELF-CENTERING AWL · Class 1
All models of SKYLINE (8)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034215372), received between Jun 28, 2018 and Oct 16, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (4 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.
Reports received per month
Most reported problems
Device problems
- Break4
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 16, 2023Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE INNER SHAFT OF THE SELF CENTERING SKYLINE AWL BROKE WHILE BEING USED BY THE SURGEON. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) SKY SELF CENTERING AWL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17940814 ↗MalfunctionMay 27, 2021Break; Break
DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: SKYLINE SELF CENTERING AWL ((B)(4)) BROKE. TIP SEPARATED FROM HANDLE, LIKELY DUE TO NORMAL WEAR AND TEAR. HAPPENED AFTER SURGERY, NO IMPACT ON THE SURGERY OR PATIENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) SKY SELF CENTERING AWL. THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11896456 ↗MalfunctionJun 28, 2018Break; Break
SELF CENTERING AWL TIP BROKE WHEN PRESSURE WAS APPLIED TO THE ANTERIOR ASPECT OF VETEBRAL BODY. PATIENT CONSEQUENCE? :NO.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7646560 ↗MalfunctionJun 28, 2018Break; Break
SELF CENTERING AWL TIP BROKE WHEN PRESSURE WAS APPLIED TO THE ANTERIOR ASPECT OF VERTEBRAL BODY. PATIENT CONSEQUENCE? NO.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7646509 ↗
Other AWL devices
- Meridian RA2-003015Seaspine Orthopedics Corporation · AWL1 recall1 report
- AMP 117-165Alphatec Spine, Inc. · AWL1 recall0 reports
- SYNFIX Evolution 03.835.032Synthes GmbH · AWL16 reports
- NA 359.213Synthes GmbH · AWL7 reports
- NA 03.010.041Synthes GmbH · AWL7 reports
- ENDOSKELETON® TAS 2300-1110Medtronic Sofamor Danek, Inc. · AWL7 reports
- NA 03.820.100Synthes GmbH · AWL6 reports
- Endoskeleton™ TCS Interbody System 5210-1063Medtronic Sofamor Danek, Inc. · Awl5 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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