SKYLINE 286840000Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10705034215457), received between Nov 7, 2017 and Mar 20, 2026 — classified as 1 injury, 57 malfunctions.

The most frequently reported specific device problem is “Break” (41 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. 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 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2026Break

  DURING A PROCEDURE, THE SKYLINE CAM TIGHTENER SHAFT TIP SNAPPED ON FINAL TIGHTENING. TIP WAS RETRIEVED FROM THE PLATE, X-RAY TAKEN TO CONFIRM NO FRAGMENTS IN THE PATIENT. SECOND CAM SHAFT FROM THE TRAY WAS USED. THERE WAS NO DELAY TO THEATRE. NO INJURY TO THE PATIENT AND NO DELAY TO THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24651722 ↗
• MalfunctionDec 22, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SELF RETAINING DRIVER APPEARED TO BE STRIPPED AND WAS NO LONGER RETAINING SCREWS. THE NURSE WAS REQUIRED TO USE SOME BONE WAX ON TIP OF DRIVER TO AID IN RETAINING SCREW. THE NURSES ALSO NOTED THAT THE CAM SCREWDRIVER WAS BEGINNING TO LOOK STRIPPED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23862562 ↗
• MalfunctionNov 7, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THE SCREW DRIVER SHAFTS WERE STRIPPED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496703 ↗
• MalfunctionNov 7, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THE SCREW DRIVER SHAFTS WERE STRIPPED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496532 ↗
• MalfunctionOct 15, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE DRIVERS WERE STRIPPED FROM OVERUSE. THE SINGLE-INNER SETSCREW WON¿T STAY IN DRIVER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23291296 ↗
• MalfunctionAug 20, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A ANTERIOR CERVICAL PLATING WITH SKYLINE SYSTEM, AT THE FINAL STAGE OF THE SURGERY, WHEN ALL CAMS NEED TO BE LOCKED INTO THE SKYLINE PLATE, A TORQUE HANDLE IS USED WITH A CAM TIGHTENER SHAFT. DURING THE TIGHTENING OF THE CAM THE TIP OF THE DRIVER SHAFT TWISTS, RENDERING THE INSTRUMENT USELESS. AS THE TORQUE-LIMITING HANDLE FROM THE SKYLINE SET IS USED (AND HAS BEEN CHECKED FOR THE CORRECT SETTING) AN OVER-TIGHTENING IS NOT POSSIBLE. A SECOND SHAFT WAS USED TO COMPLETE SURGERY SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22848827 ↗
• MalfunctionJul 22, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THE SALES REP NOTICED THAT X1 OF LOCKING DRIVER LOOKED STRIPPED AND SHOULD BE REPLACED. NO SURGICAL DELAY. DRIVER WAS HANDED OFF SURGICAL FIELD AND TAGGED FOR REPLACEMENT. PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22568859 ↗
• MalfunctionJun 2, 2025Break; Break

  IT WAS REPORTED THE DISTAL TIP OF THE SKYLINE CAMLOCK FINAL TIGHTENER INSTRUMENT SNAPPED WHILE FINAL TIGHTENING THE PLATE¿S CAMLOCK MECHANISM. NO FRAGMENTS WERE RETAINED IN THE PATIENT; THEY WERE REMOVED SIMPLY WITH FORCEPS. THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS, A FIVE (5) MINUTE SURGICAL DELAY AND NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22123825 ↗
• MalfunctionFeb 18, 2025Break; Break

  IT WAS REPORTED THAT THE CAM TIGHTER SHAFT OF THE SKYLINE PLATE WAS USED DURING THE SURGERY TO LOCK THE SCREWS. WHILE ROTATING THE TIGHTENED BROKE. FRAGMENTS WERE GENERATED AND WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS A 10 MINUTES OF SURGICAL DELAY. THE OTHER AVAILABLE TIGHTENER WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21403865 ↗
• MalfunctionJan 28, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE CAM TIGHTENER DRIVER WAS STRIPPED. NO FRAGMENTS WERE GENERATED. A SECOND DRIVER IN TRAY WAS THEN USED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21253436 ↗
• MalfunctionOct 2, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE EVENT WAS REPORTED WITHIN 30 MINUTES POST-OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20353115 ↗
• MalfunctionJul 11, 2024Break; Break

  IT WAS REPORTED THE TIP OF THE TIGHTENER SHAFT SNAPPED OFF WHILE IN USE. THERE WAS NO SURGICAL DELAY REPORTED. THIS REPORT IS FOR A TIGHTENER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19722436 ↗
• MalfunctionJun 6, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE 2 TIPS OF THE CAM LOCKING BROKE WHILE THE PLATE LOCKING. THE FRAGMENTS WERE EASILY REMOVED. THE SURGEON CHANGED THE CAM. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CAM TIGHTENER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19476681 ↗
• MalfunctionMay 6, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A SPINAL FUSION PROCEDURE ON (B)(6) 2024, THE NURSES WERE HAVING ISSUES LOADING THE SCREWS WITH THE CADDY AND THE EXPANSION TIP SCREWDRIVERS (2). AS WELL, THE SURGEON STRIPPED AND BROKE THE CAM TIGHTENER. HE WAS ABLE TO RETRIEVE THE BROKEN PIECE, WHICH WAS SUBSEQUENTLY DISCARDED. THE PATIENT DID NOT SUFFER FROM CONSEQUENCES AND THERE WAS NO DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR A SKY CAM TIGHTENER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19253339 ↗
• MalfunctionFeb 12, 2024Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024 DURING AN UNKNOWN PROCEDURE, THE TIP OF ONE END OF THE SCREWDRIVER SHAFT IN QUESTION WAS FOUND TO BE WORN OFF AND STRIPPED. THERE WAS NO ADVERSE PATIENT IMPACT. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CAM TIGHTENER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18685582 ↗
• MalfunctionFeb 5, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE DRIVE TIP OF SKYLINE CAM TIGHTENER SHAFT SNAPPED OFF INTRA-OPERATIVELY WHEN THE SURGEON WENT TO FINAL TIGHTEN CAM LOC MECHANISM ON THE SKYLINE PLATE. THE DRIVER TIP WAS IMMEDIATELY RETRIEVED AND TAKEN OUT OF THE PATIENT. THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) SKY CAM TIGHTENER SHAFT THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4)

  Patient problems: Insufficient Information

  MAUDE report 18641875 ↗
• MalfunctionJan 17, 2024Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE TIP OF THE DEVICE BROKE OFF IN THE PATIENT. IT WAS REMOVED AND PROCEDURE WAS CONTINUED. ANOTHER SHAFT ON THE SET WAS USED. THERE WAS NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS REPORTED AS FINE. THIS REPORT IS FOR ONE (1) SKY CAM TIGHTENER SHAFT THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18530362 ↗
• MalfunctionDec 1, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON NOVEMBER 9, 2023, THE TIP OF THE CAM TIGHTENER SHAFT BROKE WHILE BEING USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO PATIENT CONSEQUENCE. THE FRAGMENTS GENERATED WERE EASILY REMOVED WITHOUT REQUIRING ADDITIONAL INTERVENTION. THIS REPORT INVOLVES ONE SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CAM TIGHTENER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18248384 ↗
• MalfunctionAug 21, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIP OF THE CAM TIGHTENER SHAFT FROM THE SKYLINE SYSTEM SHEARED OFF IN THE SCREW HEAD AND COULD NOT BE REMOVED. THE SURGEON ATTEMPTED TO REMOVE IT WITH GRASPERS, NEEDLES, ETC., BUT WAS UNABLE TO DO SO. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT INVOLVES ONE SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CAM TIGHTENER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17585544 ↗
• MalfunctionMar 28, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE TIP OF THE CAM TIGHTENER SHAFT BROKE OFF WHILE TIGHTENING THE CAM LOCKS. THE SURGERY WAS DELAYED BY 3 MINUTES DUE TO THE EVENT, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE FRAGMENTS GENERATED WERE EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CAM TIGHTENER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16629423 ↗
• MalfunctionMar 21, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT A CAM TIGHTENER - SHAFT, TIP BROKE. UNKNOWN IF THE EVENT OCCUR DURING STERILE PROCESSING OR DURING FIELD INSPECTION. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) SKY CAM TIGHTENER SHAFT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16586580 ↗
• MalfunctionMar 16, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE DR. WAS DOING A C2-4 ACDF USING A LOAN SKYLINE KIT. HE IMPLANTED A 42MM PLATE (REF: 186.02.042) FROM THE LOAN SET AND AFTER DOING AN INTRAOP X-RAY HE DECIDED HE NEEDED TO REMOVE THE PLATE AND ADJUST IT. WHEN UNLOCKING THE CAM LOCKS THE DRIVER (2868-04-000) BURRED 1 OF THE CAM LOCKS AND IT MADE IT IMPOSSIBLE TO DISENGAGE THE LOCK. THE SCREW WAS NOT ABLE TO BE REMOVED FROM THE PLATE. THE SCREW HAD TO BE REVERSED WHILE STILL INSIDE THE PLATE. THE SAME SIZE PLATE FROM ANOTHER SET WAS USED TO COMPLETE THE SURGERY. THE SURGERY WAS DELAYED FOR 10 MINUTES. WHEN EVENT OCCURRED 2 SET OF IMPLANTS WAS OPENED AND USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. NO PATIENT OUTCOME/ CONSEQUENCES. THIS REPORT IS FOR ONE (1) SKY CAM TIGHTENER SHAFT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16552427 ↗
• MalfunctionFeb 21, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE SKYLINE CAM TIGHTENER SHAFT TIP SNAPPED. THIS COMPLAIN INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) SKY CAM TIGHTENER SHAFT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16413963 ↗
• MalfunctionOct 17, 2022Break; Break

  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 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15616481 ↗
• MalfunctionSep 30, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INSPECTION OF THE LOAN KIT FOR A PROCEDURE, IT WAS NOTICED THAT THE CAM LOCKING INSTRUMENT WAS DAMAGED ON ONE END. THERE WERE NO ISSUES FOR THE SCHEDULED PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CAM TIGHTENER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15509617 ↗