SKYLINE 186852016Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034134253), received between Sep 14, 2020 and Sep 14, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2020 THAT THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE SCREWS WERE FALLING OF THE SCREWDRIVER. THE SCRUB NURSE HAD PROBLEMS WHILE PICKING UP SCREWS FROM THE SCREW CADDY AS THEY WERE SINKING INTO THE TOP PLASTIC LAYER WHERE THEY GOT STUCK AND WERE HARD TO GET OUT. UPON EXAMINATION OF THE SCREW CADDY WE NOTICED THAT THE TOP PLATE IS ELEVATED AND THE SCREWS THAT ARE HOLDING IT IN PLACE ARE HOLDING IT ARE DEFORMED/DISPLACED. DURING THE SURGERY (2 LEVEL), SOME OF THE SCREWS HAD TO BE REPLACED WITH LARGE DIAMETER SCREWS. SURGEON WAS UNABLE TO REMOVE 3 OF THE SCREWS AND HAD TO LEAVE THEM IN PLACE ALTHOUGH THEY WERE NOT FIXATED IN THE BONE ¿ HE MANAGED TO UNSCREW THEM BUT COULD NOT TAKE THEM OUT OF THE BONE/SKYLINE PLATE. THEY HAD TO FINISH THE SURGERY WITH THE 3 SCREWS NOT FIXED INTO THE BONE BUT LOCKED INTO THE PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH 45 MINUTES DELAY. THERE WERE NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) SKY VARIABLE S-T SCW 16MM TI. THIS IS REPORT 8 OF 9 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10529348 ↗

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-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
• 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-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
• 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-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