SKYLINE 286830700Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705034215440), received between Sep 14, 2020 and Jun 25, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (7 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2025, THE SCREWDRIVERS SEEMED TO STRIP DURING SCREW PLACEMENT. PATIENT STATUS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331639 ↗
• MalfunctionJun 25, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2025, THE SCREWDRIVERS SEEMED TO STRIP DURING SCREW PLACEMENT. PATIENT STATUS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331638 ↗
• MalfunctionOct 27, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN ANTERIOR CERVICAL FUSION PROCEDURE, THE SCRUB TECH WAS TRYING TO LOAD A SCREW ONTO THE SELF RETAINING X25 DRIVER AND IT WAS NOT WORKING. THE DRIVER¿S TIP SEEMED TO BE STRIPPED. THEY IMMEDIATELY REMOVED IT FROM THE FIELD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SKYLINE ANTERIOR CERVICAL PLATE SYSTEM MEDIUM GRIP TAPERED DRIVER X15. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15683078 ↗
• MalfunctionJan 31, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING A PROCEDURE THE SCREWDRIVER WAS STRIPPED AND WILL NOT RETAIN THE SCREW AS DESIGNED. THE TECH WENT TO LOAD THE SCREW AND IT KEPT FALLING OFF. THE SURGEON REQUESTED NOT TO USE THE DRIVER AND REPLACE IT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) MEDIUM X15 TAPERED DRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13403174 ↗
• MalfunctionDec 30, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN ANTERIOR CERVICAL FUSION SURGERY ALL THE SKYLINE SCREW DRIVERS IN THE SKYLINE SETS ARE STRIPPED. THE DRIVERS WERE FULLY STRIPPED TO WHERE THE SURGEON COULD NOT FULLY DRIVE THE SKYLINE SCREWS. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THERE WERE NO PATIENT CONSEQUENCES. PROCEDURE WAS SUCCESSFULLY COMPLETED BY OPENING ANOTHER SET. CONCOMITANT DEVICE REPORTED: SCREW (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT INVOLVES ONE (1) MEDIUM X15 TAPERED DRIVER. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11096878 ↗
• MalfunctionDec 30, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN ANTERIOR CERVICAL FUSION SURGERY ALL THE SKYLINE SCREW DRIVERS IN THE SKYLINE SETS ARE STRIPPED. THE DRIVERS WERE FULLY STRIPPED TO WHERE THE SURGEON COULD NOT FULLY DRIVE THE SKYLINE SCREWS. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THERE WERE NO PATIENT CONSEQUENCES. PROCEDURE WAS SUCCESSFULLY COMPLETED BY OPENING ANOTHER SET. CONCOMITANT DEVICE REPORTED: SCREW (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT INVOLVES ONE (1) MEDIUM X15 TAPERED DRIVER. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11096816 ↗
• MalfunctionDec 30, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN ANTERIOR CERVICAL FUSION SURGERY ALL THE SKYLINE SCREW DRIVERS IN THE SKYLINE SETS ARE STRIPPED. THE DRIVERS WERE FULLY STRIPPED TO WHERE THE SURGEON COULD NOT FULLY DRIVE THE SKYLINE SCREWS. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THERE WERE NO PATIENT CONSEQUENCES. PROCEDURE WAS SUCCESSFULLY COMPLETED BY OPENING ANOTHER SET. CONCOMITANT DEVICE REPORTED: SCREW (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT INVOLVES ONE (1) MEDIUM X15 TAPERED DRIVER. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11096766 ↗
• 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) MEDIUM X15 TAPERED DRIVER. THIS IS REPORT 1 OF 9 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10529354 ↗
• 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) MEDIUM X15 TAPERED DRIVER. THIS IS REPORT 4 OF (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10529346 ↗
• 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) MEDIUM X15 TAPERED DRIVER. THIS IS REPORT 3 OF 9 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10529344 ↗