SKYLINE 186802030Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034133676), received between Jan 19, 2018 and Mar 2, 2018 — classified as 3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SPINE REVISION: (B)(6) HOSPITAL (B)(6) 2018. PRIMARY IMPLANT DATE: (B)(6) 2017. POST INITIAL FIXATION PATIENT HAS SUSTAINED A FALL, WHICH HAS LED TO FURTHER INJURY TO CERVICAL SPINE. HARDWARE REMOVED TO TRY AND ALLEVIATE SYMPTOMS ASSOCIATED WITH NEW INJURY. (B)(6). SPD: PRODUCT CODE 186802030: 30 MM 2 LEVEL SKYLINE X 1 = DISCARDED. SPD: PRODUCT CODE 186850012: 12 MM VASD SCREWS X 6 = DISCARDED.

  Patient problems: Not Applicable; Pain; Spinal Column Injury

  MAUDE report 7309875 ↗
• InjuryJan 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VIVIGEN: IT WAS REPORTED THAT A SUBJECT EXPERIENCED SYMPTOMATIC LUMBAR STENOSIS WITH ASSOCIATED BACK AND LEG PAIN. THE SUBJECT IS SCHEDULED FOR POSTERIOR INTERBODY LUMBAR FUSION ON (B)(6) 2018.

  Patient problems: High Blood Pressure/ Hypertension; Pain; Spinal Column Injury

  MAUDE report 7215878 ↗
• InjuryJan 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VIVIGEN REPORTED THAT A PATIENT WITH DEGENERATIVE DISC DISEASE AND A HISTORY OF BILATERAL KNEE PAIN, BILATERAL WRIST PAIN, AND LOWER BACK PAIN, WAS IMPLANTED WITH A 30MM SKYLINE ANTERIOR CERVICAL PLATE AT LEVELS C-5-C6, C6-C7 ALONG WITH TWO VERTIGRAFT VG1 CERVICAL-7 DEGREE LORDOSIS PRESERVON SPACERS AND VIVIGIN ON (B)(6) 2017. THE PATIENT WAS LATER DIAGNOSED WITH BASAL CELL CARCINOMA OF THE FOREHEAD AND LEFT FOREARM AFTER AN EVALUATION (B)(6) 2017. THE DATE OF ONSET OF THE CARCINOMA IS REPORTEDLY (B)(6) 2017. THIS COMPLAINT INVOLVES DEVICES.

  Patient problems: Cancer

  MAUDE report 7205237 ↗

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-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-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
• 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-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