SKYLINE 286830500Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 10705034215426), received between Jun 5, 2017 and Sep 23, 2026 — classified as 73 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 73 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Device-Device Incompatibility; Material Deformation

  It was reported that the screw driver tip was bent and would not engage on the screw. This did not happen during the procedure. The bent screwdriver was found when they opened the kit for the case.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867747 ↗
• MalfunctionJul 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50083931 ↗
• MalfunctionMay 15, 2026Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THE SCREWDRIVER NO LONGER HOLDS THE SCREWS IN PLACE. NO PATIENT HARM. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25183326 ↗
• MalfunctionMay 15, 2026Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THE SCREWDRIVER NO LONGER HOLDS THE SCREWS IN PLACE. NO PATIENT HARM. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25183305 ↗
• MalfunctionMar 17, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE SKY EXPANSION TIP SCREWDRIVER FAILED DURING INTRA-OPERATIVE USE. THE ALLEGATION INVOLVED FOUR SCREWDRIVERS THAT WERE NOT RETAINING SCREWS, RESULTING IN SCREWS FALLING OFF THE DRIVER. THE EVENT OCCURRED AT A HOSPITAL, AND THE AFFECTED DEVICES WERE SHIPPED BACK AND ARE AVAILABLE FOR RETURN. THERE WAS NO PATIENT INVOLVEMENT OR OBSERVABLE CLINICAL SYMPTOMS ASSOCIATED WITH THE EVENT, AND THE DRIVE FEATURE OF THE DEVICE WAS DESCRIBED AS DAMAGED, WORN, OR STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617474 ↗
• MalfunctionMar 17, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE SKY EXPANSION TIP SCREWDRIVER FAILED DURING INTRA-OPERATIVE USE. THE ALLEGATION INVOLVED FOUR SCREWDRIVERS THAT WERE NOT RETAINING SCREWS, RESULTING IN SCREWS FALLING OFF THE DRIVER. THE EVENT OCCURRED AT A HOSPITAL, AND THE AFFECTED DEVICES WERE SHIPPED BACK AND ARE AVAILABLE FOR RETURN. THERE WAS NO PATIENT INVOLVEMENT OR OBSERVABLE CLINICAL SYMPTOMS ASSOCIATED WITH THE EVENT, AND THE DRIVE FEATURE OF THE DEVICE WAS DESCRIBED AS DAMAGED, WORN, OR STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617465 ↗
• MalfunctionMar 17, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE SKY EXPANSION TIP SCREWDRIVER FAILED DURING INTRA-OPERATIVE USE. THE ALLEGATION INVOLVED FOUR SCREWDRIVERS THAT WERE NOT RETAINING SCREWS, RESULTING IN SCREWS FALLING OFF THE DRIVER. THE EVENT OCCURRED AT A HOSPITAL, AND THE AFFECTED DEVICES WERE SHIPPED BACK AND ARE AVAILABLE FOR RETURN. THERE WAS NO PATIENT INVOLVEMENT OR OBSERVABLE CLINICAL SYMPTOMS ASSOCIATED WITH THE EVENT, AND THE DRIVE FEATURE OF THE DEVICE WAS DESCRIBED AS DAMAGED, WORN, OR STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617406 ↗
• MalfunctionJan 21, 2026Corroded

  IT WAS REPORTED THE SCREWDRIVER WAS CORRODED. NO PATIENT IMPACT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24130730 ↗
• 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 23862552 ↗
• MalfunctionDec 16, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED: A. DATE OF EVENT (IF AVAILABLE): - UNSURE EXACT DATE OF EVENT - HOSPITAL EMPLOYEES UNSURE AS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23822121 ↗
• MalfunctionNov 17, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE, IT WAS FOUND THAT INSTRUMENTS HAVE WORN DOWN AND STRIPPED DUE TO USAGE OVER TIME. THE DRILLS DID NOT CUT THROUGH BONE ADEQUATELY AND THE DRIVERS DID NOT HOLD A SCREW. THE COUPLING ON THE HANDLE WAS JARRED. ITEMS HAVE BEEN REMOVED FROM CIRCULATION. MULTIPLE SETS NEEDED TO BE OPENED TO FIND ALTERNATION INSTRUMENTS. THERE WAS A 10 MINUTES OF SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23570631 ↗
• MalfunctionMay 5, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SCREWDRIVER TIP DOES NOT RETAIN SCREW. SCREWS FALL OFF WHEN NURSE ATTEMPTS TO LOAD AND HAND TO SURGEON. THERE WAS NO DELAY IN SURGERY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21961832 ↗
• MalfunctionApr 1, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025 WHILE PLACING SCREWS AND THE SELF RETAINING EXPANSION SCREWDRIVER WAS NOT HOLDING THE SCREW. EXPANSION SCREWDRIVER WAS REMOVED FROM CASE. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES AND SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21742253 ↗
• MalfunctionMar 19, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE EXPANSION HEAD SCREWDRIVER NO LONGER RETAIN SCREWS. NO SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. NO FRAGMENTS GENERATED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21644893 ↗
• MalfunctionMar 19, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE EXPANSION HEAD SCREWDRIVER NO LONGER RETAIN SCREWS. NO SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. NO FRAGMENTS GENERATED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21643756 ↗
• MalfunctionMar 18, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2025, THE SCREW DRIVER STRIPPED OUT SO THE SHAFT AND SLEEVE ARE NO LONGER SELF RETAINING. THE PATIENT'S BONE WAS STRONG AND THE DRIVER COULD NOT WITHSTAND THE FORCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO GENERATION OF FRAGMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21635406 ↗
• MalfunctionMar 4, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE NURSE ON THE BACK TABLE FOUND THAT ALL SKYLINE SCREWDRIVERS WERE NOT PROPERLY HOLDING THE SCREW. THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21513760 ↗
• MalfunctionMar 4, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE DRIVER TIPS DID NOT HOLD THE SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21513645 ↗
• MalfunctionMar 4, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE DRIVER TIPS DID NOT HOLD THE SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21513626 ↗
• MalfunctionMar 4, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE NURSE ON THE BACK TABLE FOUND THAT ALL SKYLINE SCREWDRIVERS WERE NOT PROPERLY HOLDING THE SCREW. THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21513588 ↗
• MalfunctionSep 11, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AUGUST 22, 20024, THE SALES REPRESENTATIVE NOTICED THAT SCREWDRIVERS WERE NOT RETAINING SCREWS WELL. A SECOND SKYLINE SET'S DRIVERS WERE RETAINING SCREWS BETTER. THE REPRESENTATIVE DECIDED TO REPLACE WITH NEW DRIVERS. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A SKYLINE EXPANSION TIP DRIVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20192491 ↗
• MalfunctionSep 11, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AUGUST 22, 2024, THE SALES REPRESENTATIVE NOTICED THAT SCREWDRIVERS WERE NOT RETAINING SCREWS WELL. A SECOND SKYLINE SET'S DRIVERS WERE RETAINING SCREWS BETTER. THE REPRESENTATIVE DECIDED TO REPLACE WITH NEW DRIVERS. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A SKYLINE EXPANSION TIP DRIVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20192357 ↗
• MalfunctionJul 2, 2024Device-Device Incompatibility; Device-Device Incompatibility

  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 SKYLINE ANTERIOR CERVICAL PLATE SYSTEM EXPANSION TIP SCREWDRIVER. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19655520 ↗
• MalfunctionJul 2, 2024Device-Device Incompatibility; Device-Device Incompatibility

  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 SKYLINE ANTERIOR CERVICAL PLATE SYSTEM EXPANSION TIP SCREWDRIVER. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19655481 ↗
• MalfunctionApr 2, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON MARCH 15, 2024, THAT THE SURGEON UNABLE TO CORRECTLY LOAD OR INSERT SCREWS AS THREADS ON THE EXPANSION SCREWDRIVER TIP APPEARED TO BE WARPED AND NO LONGER IN A STRAIGHT POSITION TO RETAIN THE SCREW. THERE WAS NO SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT OUTCOME AND CONSEQUENCES. THIS REPORT IS FOR ONE (1)SKYLINE EXPANSION TIP DRIVER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19020442 ↗