SKYLINE 186802032Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034133683), received between Feb 26, 2018 and Aug 27, 2020 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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.

• InjuryAug 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT DEVELOPED HEMATOMA HOURS AFTER C5/6, C6/7 ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) WAS PERFORMED USING ANTERIOR CERVICAL CORPECTOMY AND FUSION (AACF) CAGES, SKYLINE PLATES AND SCREWS, DBX PUTTY. REVISION SURGERY WAS COMPLETED ON (B)(6) 2020. DURING REVISION SURGERY, THE HARDWARE WAS REMOVED TO REEXAMINE SURGICAL SITE FOR BLEEDING BUT RE-IMPLANTED AFTER EXAMINATION WAS COMPLETED. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) SKY 2 LEVEL PLTE 32MM TI. THIS IS REPORT 1 OF 8 FOR (B)(4).

  Patient problems: Hematoma; No Code Available

  MAUDE report 10462949 ↗
• MalfunctionOct 21, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ANTERIOR CERVICAL DISCECTOMY AND FUSION: (B)(6). SURGEON WAS CONDUCTING A C5/6/7 ANTERIOR CERVICAL DISCECTOMY AND FUSION ON PATIENT. SURGEON HAD PLACED INTERBODY SPACERS AND WAS SUPPLEMENTING FUSION WITH THE FIXATION OF AN ANTERIOR 'SKYLINE' 32MM PLATE. WHILST USING THE VARIABLE ANGLE AWL TO BREAK CORTICAL BONE THROUGH THE SCREW HOLES OF THE PLATE SURGEON NOTED A SLITHER OF METAL DEBRIS THAT HAD 'CHIPPED OFF' THE RIM OF THE SCREW HOLE (PHOTO OF DEBRIS CAN BE PROVIDED ON REQUEST). INSPECTION OF THE PLATE SHOWED NO FURTHER DAMAGE AND SURGEON ASSESSED PLATE AS BEING STRUCTURALLY SOUND TO CONTINUE TO USE FOR IMPLANTATION SO PRODUCT WILL NOT BE PROVIDED FOR INVESTIGATION. AT THIS STAGE ADVERSE EVENT HAS HAD NO IMPACT ON PATIENT OUTCOME, SURGICAL OPERATING TIME, PATIENT BLOOD LOSS OR LENGTH OF STAY. PATIENT ID: (B)(6), MALE, DOB: (B)(6). CONCOMITANT DEVICE REPORTED: UNKNOWN AWL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1) THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 9215309 ↗
• InjuryFeb 26, 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 INCREASED (PRE-EXISTING) LOW BACK PAIN, POST-OPERATIVELY (DATE OF ONSET: (B)(6) 2018). STUDY SUBJECT 16-010.

  Patient problems: Pain

  MAUDE report 7296775 ↗

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-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-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-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-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-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