SKYLINE 186803048Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034133799), received between Mar 30, 2018 and Jun 15, 2018 — 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.

• InjuryJun 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VIVIGEN: IT WAS REPORTED THAT AN ADVERSE EVENT OF BURNING PAIN OVER POSTERIOR SPINE. STUDY SUBJECT 18-007. CONCOMITANT MEDICAL PRODUCTS: BL-1500-001, VIVIGEN POUCHES 1CC, QTY 2, 77101074, BIO AVS C-OPEN 4=14(W) X 12(D), QTY 2, 77101064, BIO AVS C-OPEN 4= H=6MM 4= LORDOSIS.

  Patient problems: Burning Sensation; Pain

  MAUDE report 7606513 ↗
• InjuryMar 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) STUDY SUBJECT (B)(6). IT WAS REPORTED PATIENT HAS EXPERIENCED THE FOLLOWING: INCREASE NECK PAIN STARTED AFTER READING WITH STIFFNESS THEN PAIN BILATERAL ARM PAIN WITH HEAVINESS, ACHING FROM SHOULDERS TO HAND, RADIATES FROM NECK PER PATIENT BILATERAL LOWER EXTREMITY NUMBNESS/TINGLING- HAS PREEXISTING LOW BACK PAIN WITH RADICULOPATHY RIGHT HAND NERVE PAIN-PREEXISTING CONDITION, HAS INCREASED IN INTENSITY CONCOMITANT DEVICES: VG1C-T57P (SPACER), LOT 171550-1032 (1), VG1C-T68P (SPACER), LOT 1713536-1035 (1), BL-1500-001 (POUCH), LOT 1714530-8029 (1)

  Patient problems: Hypoesthesia; Nerve Damage; Pain

  MAUDE report 7385162 ↗

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-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-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-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-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