SKYLINE 186850018Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034134123), received between Jul 2, 2020 and Nov 4, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING A SKYLINE REVISION BROKE A SCREW WHILE TURNING OUT. THE DOCTOR SUSPECTS THAT THE SCREW HAD ALREADY BEEN BROKEN BEFORE. SURGERY WAS DELAYED 20 MINUTES. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY WINCE FRAGMENTS WERE GENERATED AND IT IS UNKNOWN IF THEY WERE REMOVED WITHOUT ADDITIONAL INTERVENTION. THE SKYLINE-PLATE WAS NOT REMOVED, BUT THE REST OF THE SCREW WAS LEFT IN. AND IN THE HOLE NEXT TO IT A STRONGER SCREW (OVERSIZED) IS USED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20602133 ↗
• InjuryJul 27, 2022Migration; Migration

  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 VARIABLE S-D SCW 18MM TI. THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).

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

  MAUDE report 15113542 ↗
• InjuryJul 27, 2022Migration; Migration

  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 VARIABLE S-D SCW 18 MM TI. THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

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

  MAUDE report 15113474 ↗
• MalfunctionOct 14, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICE WAS RECEIVED FOR INVESTIGATION. THE DEVICE APPEARS TO BE BROKEN. THIS REPORT INVOLVES 1 SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 X 18MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12634422 ↗
• InjuryJul 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THERE WAS A REQUEST FOR MANUFACTURING DOCUMENTS RELATED TO COMPLAINT (B)(4). THE COMPLAINT IS FOR METAL ABRASION AGAINST THE METAL IMPLANTS THAT WERE IMPLANTED WITH PEEK SPACERS. THIS REPORT IS FOR ONE (1) SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 X 18 MM. THIS IS REPORT 5 OF 9 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10224583 ↗

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-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
• 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-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-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