SKYLINE 286820014Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034215310), received between Jul 27, 2023 and Jul 27, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE SURGEON WAS DRILLING THE HOLE FOR THE SCREW USING THE VARIABLE DRILL GUIDE AND THE 12MM DRILL TO THE CORRECT PROTOCOL AS PER THE SURGICAL TECHNIQUE. IT WAS NOTICED THAT THE DRILL HAD SNAPPED. THE PATIENT WAS X-RAYED AND IT WAS SEEN THAT THE DRILL HAD SNAPPED INSIDE THE VERTEBRAL BODY OF THE PATIENT. THE SURGEON DETERMINED THAT THE DRILL END THAT HAD SNAPPED OFF COULD NOT BE RETRIEVED USING THE OPERATE SET, AND THE PIECE WAS LEFT IN SITU. ALL OTHER SCREWS IN THE PLATE WERE INSERTED WITHOUT ISSUE AND FINAL TIGHTENED. THERE WAS NO DELAY IN SURGERY. IT IS UNKNOWN IF THERE WAS A PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE SKYLINE ANTERIOR CERVICAL PLATE SYSTEM DRILL 2.2 X 14MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 17406609 ↗