SKYLINE 186801030Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034133638), received between Dec 27, 2023 and Oct 23, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

7 other recalls cover devices cleared under the same FDA submission (K052552, K171439); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A SPINAL PROCEDURE ON (B)(6) 2024. A SKYLINE PLATE WAS USED. THE SURGEON TRIED TO BEND IT AND WAS UNHAPPY ABOUT THE BENDING ABILITY OF THE PLATE. THEY INCREASED FORCE AND THE PLATE BROKE. ANOTHER PLATE WAS USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TEN-MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20514228 ↗
• MalfunctionDec 27, 2023Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN DECEMBER 2023, THE HEALTHCARE PROFESSIONAL STATED THAT THE IMPLANT WAS BENT AND SHOWED SIGNS OF WEAR. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SKYLINE ANTERIOR CERVICAL PLATE SYSTEM ONE LEVEL PLATE 30MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18399204 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K052552, K171439. One submission often covers many models, so check the product and lot details in each record.

• Z-0627-2017 · Oct 12, 2016 · Terminated
  DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 26mm Item Code: 186852026 The SKYLINE Anterior Cervical Plate System is indicated for stabili
• Z-0628-2017 · Oct 12, 2016 · Terminated
  DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW 4.5 x 18mm Item Code: 186854018 The SKYLINE Anterior Cervical Plate System is indicated for stabilizat
• Z-0629-2017 · Oct 12, 2016 · Terminated
  DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING SCREW 4 x 18mm Item Code: 186862018 The SKYLINE Anterior Cervical Plate System is indicated for stabi
• Z-0626-2017 · Oct 12, 2016 · Terminated
  DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 20mm Item Code: 186852020 The SKYLINE Anterior Cervical Plate System is indicated for stabiliz
• Z-0624-2017 · Oct 12, 2016 · Terminated
  DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm Item Code: 186850018 The SKYLINE Anterior Cervical Plate System is indicated for stabi
• Z-0625-2017 · Oct 12, 2016 · Terminated
  DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm Item Code: 186852018 The SKYLINE Anterior Cervical Plate System is indicated for stabi
• Z-0630-2017 · Oct 12, 2016 · Terminated
  DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCREW 4.5 x 18mm Item Code: 186864018 The SKYLINE Anterior Cervical Plate System is indicated for stabil