SKYLINE 186850015Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034134093), received between Dec 10, 2020 and Dec 10, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration” (2 reports).

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.

• InjuryDec 10, 2020Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SURGEON PERFORMED A ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) CASE IN (B)(6) 2020 USING CERVIOS & SKYLINE PLATE. ON AN UNKNOWN DATE, TWO (2) SCREWS MIGRATED AND BEGAN CAUSING PAIN TO THE PATIENT. THEY WERE REMOVED IN A REVISION CASE PERFORMED ON (B)(6) 2020. THE SURGEON REPLACED THEM WITH ANOTHER TWO (2) RESCUE SCREWS. THERE IS NO FURTHER INFORMATION AVAILABLE. THE PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN CAGE(PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ); UNKNOWN SKYLINE PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ). THIS REPORT IS FOR ONE (1) SKY VARIABLE S-D SCW 15MM TI. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 10984216 ↗
• InjuryDec 10, 2020Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SURGEON PERFORMED A ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) CASE IN (B)(6) 2020 USING CERVIOS & SKYLINE PLATE. ON AN UNKNOWN DATE, TWO (2) SCREWS MIGRATED AND BEGAN CAUSING PAIN TO THE PATIENT. THEY WERE REMOVED IN A REVISION CASE PERFORMED ON (B)(6) 2020. THE SURGEON REPLACED THEM WITH ANOTHER TWO (2) RESCUE SCREWS. THERE IS NO FURTHER INFORMATION AVAILABLE. THE PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN CAGE(PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ); UNKNOWN SKYLINE PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ). THIS REPORT IS FOR ONE (1) SKY VARIABLE S-D SCW 15MM TI. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 10984134 ↗

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-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-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-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-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