SKYLINE 186803066Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034133850), received between May 18, 2021 and Oct 22, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Corroded” (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 22, 2021Mechanical Jam; Mechanical Jam

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE SKYLINE SCREWDRIVER CAM TIGHTENER SHAFT BROKE DURING A DEMONSTRATION TO THE SURGEON. THERE WAS NO PROCEDURE AND PATIENT INVOLVED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES (2) DEVICES. THIS REPORT IS FOR (1) SKYLINE ANTERIOR CERVICAL PLATE SYSTEM THREE LEVEL PLATE 66MM. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12681591 ↗
• MalfunctionMay 18, 2021Corroded; Material Discolored; Corroded; Material Discolored

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SKY 3 LEVEL PLATE WAS FOUND TO HAVE DISCOLORATION AND CORROSION. THE PROCEDURE WAS COMPLETED USING ANOTHER PLATE. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) SKY 3 LEVEL PLTE 66MM TI. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11845912 ↗

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-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-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-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-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-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