SKYLINE 186801014Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034133553), received between Jul 27, 2022 and Aug 9, 2023 — classified as 2 injuries.

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.

• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION ACDF C4/5 WITH POSSIBLE REMOVAL OF THE EXISTING NON-SYNTHES CERVICAL PLATE (C7) ON (B)(6) 2022. DURING THE PROCEDURE, THE SURGEON WAS USING ACIS SET TO IMPLANT AN ACIS PRO TI CERVICAL GRAFT. THE SURGEON EITHER HAD TO USE ZERO P AT C4/5 OR REMOVE THE PLATE TO USE ACIS AND SKYLINE. HE ENDED UP REMOVING THE PLATE AND USED ACIS AND A SKYLINE SINGLE-LEVEL PLATE. HE INSERTED THE IMPLANT AND UPON REMOVAL OF THE INSERTER REALIZED IT WAS TOO FAR. THE PATIENT PARTIALLY LOST MOTORS FROM THE CHEST DOWN. THERE WAS NO EQUIPMENT MALFUNCTION. A VARIETY OF INSTRUMENTS WERE USED TO REMOVE THE SPACER. A NEW GRAFT WAS PLACED AND THE PLATE WAS IMPLANTED WITH SCREWS. PROCEDURE WAS COMPLETED WITH AN UNKNOWN DELAY. THE PATIENT WAS TAKEN TO THE ICU AND HAS NOT PROGRESSED VERY WELL. ONCE THE CASE WAS COMPLETED, NEURO MONITORING SHOWED THAT ONE SIDE OF THE PATIENT'S BODY WAS GETTING SOME MOTOR RESPONSE WHILE THE OTHER SIDE WAS NOT. THIS REPORT IS FOR A SKY 1 LEVEL PLTE 14MM TI. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: Nerve Damage; Osteolysis

  MAUDE report 17493072 ↗
• InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT HAD A C56 ACDF ON (B)(6) 2022 USING SKYLINE AND VG2 ALLOGRAFT. POST OPERATIVELY THE PATIENT FELL DOWN THE STAIRS DISRUPTING THE IMPLANTS WHICH RESULTED IN THE LEFT C6 SCREW MIGRATING ANTERIORLY FROM THE PLATE. A REVISION SURGERY WAS COMPLETED TO REPLACE THE PLATE AND SCREWS. THE PATIENT REQUIRED A REVISION SURGERY DUE TO THE MIGRATION OF THE SCREW ANTERIORLY. THERE WAS A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT BECAUSE A REVISION SURGERY WAS DONE DUE TO THE MIGRATION OF THE SCREW ANTERIORLY. THERE IS NO FURTHER INFORMATION. THIS REPORT IS FOR ONE (1) SKY 1 LEVEL PLTE 12MM TI. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Tissue Injury

  MAUDE report 15113471 ↗

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-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-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-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-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