SKYLINE 186804064Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034133881), received between Jan 29, 2019 and Jan 29, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 29, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE SKYLINE PLATE CAM LOCK WAS NOT ENGAGING CORRECTLY AT C3 ON THE LEFT. UPON INSPECTION, THE REP NOTICED THAT IT WAS POSSIBLE, GIVEN THE ANGLE IN RELATION TO THE PLATE, THE CAM LOCK MAY NOT BE ENGAGING CORRECTLY WITH THE HEAD OF SCREW. REP RECOMMENDED TO SURGEON TO RETURN THE CAM TO ITS NEUTRAL POSITION AND BACK OUT THE SCREW BY 2MM OR REPLACE THE SCREW WITH ONE THAT WAS 2MM LONGER. BOTH SOLUTIONS GOAL WAS TO THE HAVE TO SCREW HEAD AT AN ADEQUATE HEIGHT TO SUCCESSFULLY ENGAGE WITH THE CAM LOCK MECHANISM. SURGEON DECIDED TO BACK THE ORIGINAL SCREW OUT BY 2MM. HE THEN TRIED TO RE-ENGAGE THE LOCKING MECHANISM. THE CAM LOCK SPUN BEYOND IT¿S LOCKING ZONE, WAS ¿LOOSE¿ AND NOW WAS AT A PRONOUNCED HEIGHT COMPARED BEING FLUSH WITH THE PLATE. THE CONCLUSION WAS DRAWN THAT THE CAM LOCK MECHANISM WAS BROKEN. AT THIS POINT, THE SURGEON DECIDED TO DELICATELY RETURN THE CAM TO NEUTRAL AND TACTICALLY CONFIRM SCREW PURCHASE AT C3 ON THE LEFT (THE BROKEN CAM IN QUESTION). HE STATED THAT THE RISK OF REMOVING THE ENTIRE CONSTRUCTS SCREWS, REPLACING THE PLATE AND RE-SCREWING WITH OVERSIZED RESCUE SCREWS COULD POTENTIALLY CREATE BIGGER ISSUES THAN LEAVING THE CONSTRUCT THE WAY IT W

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8287184 ↗

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-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
• 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-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-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-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-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-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