SKYLINE 186850014Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705034134086), received between Aug 16, 2018 and Oct 20, 2025 — classified as 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT DURING THE SURGERY, THE TITANIUM PLATE AND SCREW ARE STUCK, AND THE SCREW CANNOT BE UNSCREWED OR RETRACTED, CAUSING THE CAM LOCK PLATE TO FAIL TO LOCK. OTHER DEVICES WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336361 ↗
• MalfunctionJan 29, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE WHILE THE SURGEON WAS PLACING A SCREW INTO A PLATE A STRING OF WIRE DEVELOPED AS HE WAS TIGHTENING THE SCREW. THE SCREW WAS LEFT IN PLACE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21263819 ↗
• MalfunctionJan 27, 2025Break; Break

  IT WAS REPORTED THAT WHEN SURGEON WAS INSERTING 14MM SELF DRILLING VARIABLE SCREW, HE HAD A HIGH ANGULATION. SCREW WAS HITTING THE LIP OF THE SCREW HOLE ON SKYLINE PLATE. PART OF THE SCREW ENDED UP SHREDDING OFF. THERE WERE NO ISSUES WITH SCREW ITSELF, STILL FELT GOOD FEEDBACK. LEFT SCREW WAS INSERTED. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT. SHREDDED PIECE OF SCREW WAS DISCARDED OFF OF STERILE FIELD. SCREW WAS LEFT IN PLACE IN PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY. FRAGMENTS WERE GENERATED AND THEY WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WERE NO PATIENT CONSEQUENCES. NO OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21245589 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION ACDF C4/5 WITH POSSIBLE REMOVAL OF THE EXISTING NON-SYNTHES CERVICAL PLATE (C7) ON (B)(6) 2022. DURING THE PROCEDURE, THE SURGEON WAS USING ACIS SET TO IMPLANT AN ACIS PRO TI CERVICAL GRAFT. THE SURGEON EITHER HAD TO USE ZERO P AT C4/5 OR REMOVE THE PLATE TO USE ACIS AND SKYLINE. HE ENDED UP REMOVING THE PLATE AND USED ACIS AND A SKYLINE SINGLE-LEVEL PLATE. HE INSERTED THE IMPLANT AND UPON REMOVAL OF THE INSERTER REALIZED IT WAS TOO FAR. THE PATIENT PARTIALLY LOST MOTORS FROM THE CHEST DOWN. THERE WAS NO EQUIPMENT MALFUNCTION. A VARIETY OF INSTRUMENTS WERE USED TO REMOVE THE SPACER. A NEW GRAFT WAS PLACED AND THE PLATE WAS IMPLANTED WITH SCREWS. PROCEDURE WAS COMPLETED WITH AN UNKNOWN DELAY. THE PATIENT WAS TAKEN TO THE ICU AND HAS NOT PROGRESSED VERY WELL. ONCE THE CASE WAS COMPLETED, NEURO MONITORING SHOWED THAT ONE SIDE OF THE PATIENT'S BODY WAS GETTING SOME MOTOR RESPONSE WHILE THE OTHER SIDE WAS NOT. THIS REPORT IS FOR A SKY VARIABLE S-D SCW 14MM TI. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: Nerve Damage; Osteolysis

  MAUDE report 17492839 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION ACDF C4/5 WITH POSSIBLE REMOVAL OF THE EXISTING NON-SYNTHES CERVICAL PLATE (C7) ON (B)(6) 2022. DURING THE PROCEDURE, THE SURGEON WAS USING ACIS SET TO IMPLANT AN ACIS PRO TI CERVICAL GRAFT. THE SURGEON EITHER HAD TO USE ZERO P AT C4/5 OR REMOVE THE PLATE TO USE ACIS AND SKYLINE. HE ENDED UP REMOVING THE PLATE AND USED ACIS AND A SKYLINE SINGLE-LEVEL PLATE. HE INSERTED THE IMPLANT AND UPON REMOVAL OF THE INSERTER REALIZED IT WAS TOO FAR. THE PATIENT PARTIALLY LOST MOTORS FROM THE CHEST DOWN. THERE WAS NO EQUIPMENT MALFUNCTION. A VARIETY OF INSTRUMENTS WERE USED TO REMOVE THE SPACER. A NEW GRAFT WAS PLACED AND THE PLATE WAS IMPLANTED WITH SCREWS. PROCEDURE WAS COMPLETED WITH AN UNKNOWN DELAY. THE PATIENT WAS TAKEN TO THE ICU AND HAS NOT PROGRESSED VERY WELL. ONCE THE CASE WAS COMPLETED, NEURO MONITORING SHOWED THAT ONE SIDE OF THE PATIENT'S BODY WAS GETTING SOME MOTOR RESPONSE WHILE THE OTHER SIDE WAS NOT. THIS REPORT IS FOR A SKY VARIABLE S-D SCW 14MM TI. THIS IS REPORT 4 OF 6 FOR (B)(4).

  Patient problems: Nerve Damage; Osteolysis

  MAUDE report 17492533 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION ACDF C4/5 WITH POSSIBLE REMOVAL OF THE EXISTING NON-SYNTHES CERVICAL PLATE (C7) ON (B)(6) 2022. DURING THE PROCEDURE, THE SURGEON WAS USING ACIS SET TO IMPLANT AN ACIS PRO TI CERVICAL GRAFT. THE SURGEON EITHER HAD TO USE ZERO P AT C4/5 OR REMOVE THE PLATE TO USE ACIS AND SKYLINE. HE ENDED UP REMOVING THE PLATE AND USED ACIS AND A SKYLINE SINGLE-LEVEL PLATE. HE INSERTED THE IMPLANT AND UPON REMOVAL OF THE INSERTER REALIZED IT WAS TOO FAR. THE PATIENT PARTIALLY LOST MOTORS FROM THE CHEST DOWN. THERE WAS NO EQUIPMENT MALFUNCTION. A VARIETY OF INSTRUMENTS WERE USED TO REMOVE THE SPACER. A NEW GRAFT WAS PLACED AND THE PLATE WAS IMPLANTED WITH SCREWS. PROCEDURE WAS COMPLETED WITH AN UNKNOWN DELAY. THE PATIENT WAS TAKEN TO THE ICU AND HAS NOT PROGRESSED VERY WELL. ONCE THE CASE WAS COMPLETED, NEURO MONITORING SHOWED THAT ONE SIDE OF THE PATIENT'S BODY WAS GETTING SOME MOTOR RESPONSE WHILE THE OTHER SIDE WAS NOT. THIS REPORT IS FOR A SKY VARIABLE S-D SCW 14MM TI. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: Nerve Damage; Osteolysis

  MAUDE report 17492491 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION ACDF C4/5 WITH POSSIBLE REMOVAL OF THE EXISTING NON-SYNTHES CERVICAL PLATE (C7) ON (B)(6) 2022. DURING THE PROCEDURE, THE SURGEON WAS USING ACIS SET TO IMPLANT AN ACIS PRO TI CERVICAL GRAFT. THE SURGEON EITHER HAD TO USE ZERO P AT C4/5 OR REMOVE THE PLATE TO USE ACIS AND SKYLINE. HE ENDED UP REMOVING THE PLATE AND USED ACIS AND A SKYLINE SINGLE-LEVEL PLATE. HE INSERTED THE IMPLANT AND UPON REMOVAL OF THE INSERTER REALIZED IT WAS TOO FAR. THE PATIENT PARTIALLY LOST MOTORS FROM THE CHEST DOWN. THERE WAS NO EQUIPMENT MALFUNCTION. A VARIETY OF INSTRUMENTS WERE USED TO REMOVE THE SPACER. A NEW GRAFT WAS PLACED AND THE PLATE WAS IMPLANTED WITH SCREWS. PROCEDURE WAS COMPLETED WITH AN UNKNOWN DELAY. THE PATIENT WAS TAKEN TO THE ICU AND HAS NOT PROGRESSED VERY WELL. ONCE THE CASE WAS COMPLETED, NEURO MONITORING SHOWED THAT ONE SIDE OF THE PATIENT'S BODY WAS GETTING SOME MOTOR RESPONSE WHILE THE OTHER SIDE WAS NOT. THIS REPORT IS FOR A SKY VARIABLE S-D SCW 14MM TI. THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: Nerve Damage; Osteolysis

  MAUDE report 17491910 ↗
• 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 14MM TI. THIS IS REPORT 5 OF 9 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10529351 ↗
• MalfunctionSep 14, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SLOVENIA 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 14MM TI. THIS IS REPORT 9 OF 9 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10529335 ↗
• InjuryAug 16, 2018Migration; Migration

  THE PATIENT PROVIDED THE FOLLOWING INFORMATION: SINCE THE REVISION, PATIENT STILL IS EXPERIENCING ON-GOING PAIN. CT SCAN TAKEN IN (B)(6) 2018 SHOW RADIOLUCENCY AROUND THE LEFT C5-C6 SCREWS. THE PATIENT STATES THAT THE CT SCAN REPORT INDICATES A LINEAR LUCENCY EXTENDING FROM THE SUPERIOR ENDPLATE OF THE LEFT C5 VERTEBRAE CONTINUOUS WITH THE ANTERIOR CERVICAL SCREW AT C5. PATIENT ALSO STATED TWO OF THE FOUR SCREWS WERE PLACED "CROOKED". AND NOW SHE HAS A FRACTURE AT C5. THERE HAS BEEN NO FURTHER TREATMENT OR REVISION OF THE C5-C6 POSTERIOR CERVICAL FUSION. THE PATIENT HAS HAD NO FURTHER CONTACT, EXAMINATION, OR TREATMENT WITH THE IMPLANT SURGEON. PATIENT STATED NO OTHER SURGEON WILL PERFORM THE REVISION. SHE IS GOING TO SEEK ANOTHER OPINION AT CLEVELAND CLINIC. DATE UNKNOWN. PATIENT PREVIOUSLY PHONE IN COMPLAINT ON (B)(6) 2018. REPORTED PRODUCTS WERE: 04.614.014; 04.614.508. SYNTHES COMPLAINT NUMBER (B)(4).

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 7789859 ↗
• InjuryAug 16, 2018Migration; Migration

  THE PATIENT PROVIDED THE FOLLOWING INFORMATION: SINCE THE REVISION, PATIENT STILL IS EXPERIENCING ON-GOING PAIN. CT SCAN TAKEN IN (B)(6) 2018 SHOW RADIOLUCENCY AROUND THE LEFT C5-C6 SCREWS. THE PATIENT STATES THAT THE CT SCAN REPORT INDICATES A LINEAR LUCENCY EXTENDING FROM THE SUPERIOR ENDPLATE OF THE LEFT C5 VERTEBRAE CONTINUOUS WITH THE ANTERIOR CERVICAL SCREW AT C5. PATIENT ALSO STATED TWO OF THE FOUR SCREWS WERE PLACED "CROOKED". AND NOW SHE HAS A FRACTURE AT C5. THERE HAS BEEN NO FURTHER TREATMENT OR REVISION OF THE C5-C6 POSTERIOR CERVICAL FUSION. THE PATIENT HAS HAD NO FURTHER CONTACT, EXAMINATION, OR TREATMENT WITH THE IMPLANT SURGEON. PATIENT STATED NO OTHER SURGEON WILL PERFORM THE REVISION. SHE IS GOING TO SEEK ANOTHER OPINION AT CLEVELAND CLINIC. DATE UNKNOWN. CT IMAGES ATTACHED. SEE ATTACHMENTS. PATIENT PREVIOUSLY PHONE IN COMPLAINT ON (B)(6) 2018. REPORTED PRODUCTS WERE: (B)(4). SYNTHES COMPLAINT NUMBER (B)(4).

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 7789838 ↗

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-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-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-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-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-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