SKYLINE 186850012Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034134062), received between Mar 2, 2018 and Oct 17, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED ON AN UNKNOWN DATE, IT APPEARS THAT A THREAD FROM ONE OF THE SCREWS OF THE SKYLINE PLATE SOMEHOW DELAMINATED FROM THE BODY OF THE SCREW. IT UNRAVELED UNDERNEATH THE PLATE DURING INSERTION AND WASN¿T ACTUALLY VISUALIZED UNTIL THE SCREW WAS ALL THE WAY IN. AFTER REMOVING THE VISIBLE DEBRIS FROM THE WOUND THE PLATE WAS LOCKED. IT APPEARED AS IF NO DAMAGE WAS MADE TO THE CONSTRUCT, JUST A METAL DELAMINATING FROM THE THREAD ON INSERTION. ADDITIONALLY, THE CAM-LOCK TRILOBE DRIVER TIP BROKE OFF IN THE WOUND AS WELL, WHICH WAS ALSO CAREFULLY RETRIEVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 3 MINUTES. FRAGMENTS WERE GENERATED AND WERE REMOVED WITHOUT INTERVENTION.THERE WERE NO PATIENT CONSEQUENCES REPORTED. CONCOMITANT DEVICE REPORTED: UNK PLATE ( PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) SKY VARIABLE S-D SCW 12MM TI THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15616473 ↗
• 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 7309755 ↗

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-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-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-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-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-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