SKYLINE 186862012Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034134581), received between Feb 19, 2020 and Feb 19, 2020 — classified as 1 injury.

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.

• InjuryFeb 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (C6-C7) SURGERY. POST-SURGERY, THE PATIENT HAS DEVELOPED SOME SKIN CONDITION AND IS CURRENTLY UNDERGOING EXTENDED SKIN PATCH TESTING TO RULE OUT IF THE PATIENT IS NOT ALLERGIC TO ANY OF THE METALS THAT WERE PLACED INTO THE PATIENT'S NECK. THE SURGEON AND DERMATOLOGIST PERFORMED EXTENDED PATCH TESTING AND VANADIUM CHLORIDE CAME BACK POSITIVE OUT OF 80 COMMON PATCHES AFTER 48 HOURS AFTER SURGERY. MONITORING WITH ALLERGISTS AND DERMATOLOGISTS, WORKING TOGETHER TO POTENTIALLY PRESCRIBE MEDICATIONS. THE SURGEON WILL DISCUSS WHETHER OR NOT A REVISION WILL BE NECESSARY AFTER FUSION. THE PATIENT WAS IMPLANTED WITH A PLATE FROM DEPUY SPINE, ONE SCREW IS FROM DEPUY SYNTHES AND ANOTHER ONE SCREW IS FROM (B)(6) AND A CAGE FROM DEPUY SPINE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY 2). THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS 6 OF 6 FOR (B)(4).

  Patient problems: Skin Irritation

  MAUDE report 9728862 ↗

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-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-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-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-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