SKYLINE 186850016Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705034134109), received between Sep 23, 2019 and Mar 15, 2021 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (9 reports).

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMar 15, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A REMOVAL SURGERY FOR A SKYLINE PLATE/SCREWS AS THE SCREWS HAD FRACTURED. THE SCREWS HAD FRACTURED IN THE VERTEBRAL BODY AND METALS WAS SUBSEQUENTLY LEFT IN THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: BONE VERTIGRAFT CERVICAL TRAPEZOID 5*7MM (PART# S18155241049, LOT# UNKNOWN, QUANTITY 1); BONE VERTIGRAFT CERVICAL TRAPEZOID 5*7MM (PART# S17197051079, LOT# UNKNOWN, QUANTITY 1); BONE VERTIGRAFT CERVICAL/TRAP FD 6*8MM (PART# S1816613-1034, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS REPORT IS FOR (1) SKY VARIABLE S-D SCW 16MM TI. THIS REPORT IS 4 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11486143 ↗
• InjuryMar 15, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A REMOVAL SURGERY FOR A SKYLINE PLATE/SCREWS AS THE SCREWS HAD FRACTURED. THE SCREWS HAD FRACTURED IN THE VERTEBRAL BODY AND METALS WAS SUBSEQUENTLY LEFT IN THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: BONE VERTIGRAFT CERVICAL TRAPEZOID 5*7MM (PART# S18155241049, LOT# UNKNOWN, QUANTITY 1); BONE VERTIGRAFT CERVICAL TRAPEZOID 5*7MM (PART# S17197051079, LOT# UNKNOWN, QUANTITY 1); BONE VERTIGRAFT CERVICAL/TRAP FD 6*8MM (PART# S1816613-1034, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS REPORT IS FOR (1) SKY VARIABLE S-D SCW 16MM TI. THIS REPORT IS 3 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11486142 ↗
• InjuryMar 15, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A REMOVAL SURGERY FOR A SKYLINE PLATE/SCREWS AS THE SCREWS HAD FRACTURED. THE SCREWS HAD FRACTURED IN THE VERTEBRAL BODY AND METALS WAS SUBSEQUENTLY LEFT IN THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: BONE VERTIGRAFT CERVICAL TRAPEZOID 5*7MM (PART# S18155241049, LOT# UNKNOWN, QUANTITY 1). BONE VERTIGRAFT CERVICAL TRAPEZOID 5*7MM (PART# S17197051079, LOT# UNKNOWN, QUANTITY 1). BONE VERTIGRAFT CERVICAL/TRAP FD 6*8MM (PART# S1816613-1034, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS REPORT IS FOR (1) SKY VARIABLE S-D SCW 16MM TI. THIS REPORT IS 8 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11486109 ↗
• InjuryMar 15, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A REMOVAL SURGERY FOR A SKYLINE PLATE/SCREWS AS THE SCREWS HAD FRACTURED. THE SCREWS HAD FRACTURED IN THE VERTEBRAL BODY AND METALS WAS SUBSEQUENTLY LEFT IN THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: BONE VERTIGRAFT CERVICAL TRAPEZOID 5*7MM (PART# S18155241049, LOT# UNKNOWN, QUANTITY 1). BONE VERTIGRAFT CERVICAL TRAPEZOID 5*7MM (PART# S17197051079, LOT# UNKNOWN, QUANTITY 1). BONE VERTIGRAFT CERVICAL/TRAP FD 6*8MM (PART# S1816613-1034, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS REPORT IS FOR (1) SKY VARIABLE S-D SCW 16MM TI . THIS REPORT IS 6 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11486103 ↗
• InjuryMar 15, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A REMOVAL SURGERY FOR A SKYLINE PLATE/SCREWS AS THE SCREWS HAD FRACTURED. THE SCREWS HAD FRACTURED IN THE VERTEBRAL BODY AND METALS WAS SUBSEQUENTLY LEFT IN THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: BONE VERTIGRAFT CERVICAL TRAPEZOID 5*7MM (PART# S18155241049, LOT# UNKNOWN, QUANTITY 1); BONE VERTIGRAFT CERVICAL TRAPEZOID 5*7MM (PART# S17197051079, LOT# UNKNOWN, QUANTITY 1); BONE VERTIGRAFT CERVICAL/TRAP FD 6*8MM (PART# S1816613-1034, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS REPORT IS FOR (1) SKY VARIABLE S-D SCW 16MM TI. THIS REPORT IS 2 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11486096 ↗
• InjuryMar 15, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A REMOVAL SURGERY FOR A SKYLINE PLATE/SCREWS AS THE SCREWS HAD FRACTURED. THE SCREWS HAD FRACTURED IN THE VERTEBRAL BODY AND METALS WAS SUBSEQUENTLY LEFT IN THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: BONE VERTIGRAFT CERVICAL TRAPEZOID 5*7MM (PART# S18155241049, LOT# UNKNOWN, QUANTITY 1). BONE VERTIGRAFT CERVICAL TRAPEZOID 5*7MM (PART# S17197051079, LOT# UNKNOWN, QUANTITY 1). BONE VERTIGRAFT CERVICAL/TRAP FD 6*8MM (PART# S1816613-1034, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS REPORT IS FOR (1) SKY VARIABLE S-D SCW 16MM TI. THIS REPORT IS 7 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11486088 ↗
• InjuryMar 15, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A REMOVAL SURGERY FOR A SKYLINE PLATE/SCREWS AS THE SCREWS HAD FRACTURED. THE SCREWS HAD FRACTURED IN THE VERTEBRAL BODY AND METALS WAS SUBSEQUENTLY LEFT IN THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: BONE VERTIGRAFT CERVICAL TRAPEZOID 5*7MM (PART# S18155241049, LOT# UNKNOWN, QUANTITY 1); BONE VERTIGRAFT CERVICAL TRAPEZOID 5*7MM (PART# S17197051079, LOT# UNKNOWN, QUANTITY 1); BONE VERTIGRAFT CERVICAL/TRAP FD 6*8MM (PART# S1816613-1034, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS REPORT IS FOR (1) SKY VARIABLE S-D SCW 16MM TI. THIS REPORT IS 5 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11486085 ↗
• InjuryMar 15, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A REMOVAL SURGERY FOR A SKYLINE PLATE/SCREWS AS THE SCREWS HAD FRACTURED. THE SCREWS HAD FRACTURED IN THE VERTEBRAL BODY AND METALS WAS SUBSEQUENTLY LEFT IN THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: BONE VERTIGRAFT CERVICAL TRAPEZOID 5*7MM (PART# S18155241049, LOT# UNKNOWN, QUANTITY 1); BONE VERTIGRAFT CERVICAL TRAPEZOID 5*7MM (PART# S17197051079, LOT# UNKNOWN, QUANTITY 1); BONE VERTIGRAFT CERVICAL/TRAP FD 6*8MM (PART# S1816613-1034, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS REPORT IS FOR (1) SKY VARIABLE S-D SCW 16MM TI. THIS REPORT IS 1 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11486028 ↗
• 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-D SCW 16MM TI. THIS IS REPORT 2 OF 9 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10529356 ↗
• InjuryJul 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THERE WAS A REQUEST FOR MANUFACTURING DOCUMENTS RELATED TO (B)(4). THE COMPLAINT IS FOR METAL ABRASION AGAINST THE METAL IMPLANTS THAT WERE IMPLANTED WITH PEEK SPACERS. THIS REPORT IS FOR ONE (1) SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 X 16MM. THIS IS REPORT 6 OF 9 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10224628 ↗
• InjuryJul 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THERE WAS A REQUEST FOR MANUFACTURING DOCUMENTS RELATED TO COMPLAINT (B)(4). THE COMPLAINT IS FOR METAL ABRASION AGAINST THE METAL IMPLANTS THAT WERE IMPLANTED WITH PEEK SPACERS. THIS REPORT IS FOR ONE (1) SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 X 16 MM. THIS IS REPORT 1 OF 9 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10224475 ↗
• InjurySep 23, 2019Break; Break

  PATIENT FOR REVISION SURGERY AFTER SPONDYLODESIS C4/5 WITH AUTOLOGUES BONE GRAFT AND SKYLINE PLATE ON (B)(6) 2018. CURRENT REVISION SURGERY BECAUSE OF PERSISTING PAIN IN NECK AND ARMS. UNCLEAR IF LOW GRADE INFECT, NON UNION IN RADIOLOGY. DURING IMPLANT REMOVAL, IT WAS FOUND, THAT ONE OF THE SKYLINE SCREWS IN C5 WAS BROKEN. THE TIP OF THE SCREW WAS LEFT IN THE VERTEBRAL BODY BECAUSE IT WAS IMPOSSIBLE TO REMOVE. SURGERY WENT ON AS PLANNED AND A LONGER PLATE WAS IMPLANTED. REMOVED IMPLANTS WERE SEND FOR SONIFICATION AND WILL NOT BE AVAILABLE FOR EXAMINATION. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> NO, ACTION TAKEN WHEN EVENT OCCURRED? --> NONE, SCREW TIP WAS LEFT IN PLACE, WAS PROCEDURE SUCCESSFULLY COMPLETED? --> YES, WERE FRAGMENTS GENERATED? --> UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> NO, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> UNKNOWN, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, OTHER INFORMATION --> PATIENT HAS A STRONG NICKEL ALLERGY AND WAS INTENSIVELY TESTED FOR OTHER KINDS OF ALLERGY LIKE TAN, TAV, TICP BEFORE PRIMARY SURGERY. NONE OF THEM COULD BE

  Patient problems: Foreign Body In Patient; No Code Available; Pain; Unspecified Infection

  MAUDE report 9104494 ↗

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-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-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-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-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