SKYLINE 186802034Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034133690), received between Jun 5, 2018 and Jan 7, 2025 — classified as 1 death, 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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

• MalfunctionJan 7, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21095526 ↗
• DeathJun 27, 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 CARDIAC ARREST AND DEATH REPORTED STUDY SUBJECT (B)(6). CONCOMITANT DEVICES: VIVIGEN POUCH, BL-1500-001, LOT# 1811201-8019, QTY 2 (STRYKER) BIO AVS C-OPEN 4=14(W) X 12(D), 77101074, LOT# 1715826-1049 AND 1618761-1048.

  Patient problems: Cardiac Arrest; Death

  MAUDE report 7642897 ↗
• InjuryJun 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) STUD: SUBJECT (B)(6): DIAGNOSIS: INCISION AND DEBRIDEMENT OF ANTERIOR NECK. HE HAS NOTED A SMALL OF AMOUNT OF ONGOING SCANT YELLOWISH DRAINAGE/SPOTTING FROM HIS NECK INCISION, WHICH HE USUALLY NOTES ON THE PILLOW OVERNIGHT. HE STATES THAT THIS BEGAN SEVERAL WEEKS AGO AFTER SHAVING. HE HAS NOTED A SMALL PROMINENCE NEAR HIS INCISION, BUT DENIES ANY ERYTHEMA OR INDURATION. HE HAS WEANED OFF NARCOTIC PAIN MEDICATIONS, AND TAKES TYLENOL AS NEEDED OCCASIONALLY FOR PAIN. HE COMPLETED A COURSE OF BACTRIM. HE IS MAKING CONTINUED PROGRESS WITH RESOLUTION OF PAIN SYMPTOMS AND ONGOING IMPROVEMENT IN STRENGTH. HE HAS HAD SOME SPOTTING OF SEROFIBRINOUS APPEARING DRAINAGE FROM CERVICAL INCISION WHICH DOES HAVE SLIGHT NODULAR APPEARANCE AT CENTRAL PORTION OF INCISION. SMALL AMOUNT OF PURULENT APPEARING DRAINAGE WAS EXPRESSED TODAY WHICH IS NEAR HAIR FOLLICLE AND HAS APPEARANCE OF SMALL SUPERFICIAL INCLUSION CYST OR INGROWN HAIR. PERFORMED LANCING OF CYST WHICH WAS VERY SUPERFICIAL AND HAD MINIMAL ADDITIONAL DRAINAGE, BUT MOSTLY BLEEDING. NO TRACKING OF POCKET. INCISION WAS REDRESSED WITH 4X4 AND TEGADERM. WILL CONTINUE DAILY DRESSING CHANGES AND PLAN FOR COMPLETION OF ADDITIONAL WEEK OF ABX

  Patient problems: Pain; Unspecified Infection

  MAUDE report 7569258 ↗

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-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-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-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-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-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-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