SKYLINERecalls & reported problems across all models
Medos International Sàrl · 39 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 217
- Deaths reported
- 1
- Injuries reported
- 55
- Recalls
- 0
We found 39 models of SKYLINE by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 217 adverse event reports in the FDA's MAUDE database, received between Jun 5, 2017 and Sep 23, 2026 — classified as 1 death, 55 injuries, 161 malfunctions.
The most frequently reported specific device problem is “Break” (69 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported SKYLINE problems
Device problems
- Break69
- Device-Device Incompatibility53
- Material Twisted/Bent53
- Adverse Event Without Identified Device or Use Problem36
- Migration9
- Material Deformation8
- Mechanical Jam4
- Entrapment of Device3
Patient problems
- No Clinical Signs, Symptoms or Conditions128
- No Consequences Or Impact To Patient28
- No Code Available17
- Pain13
- Hematoma7
- Nerve Damage6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available5
- Foreign Body In Patient5
SKYLINE models
39 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SKYLINE 286830500DRIVER, PROSTHESIS73 reports
- SKYLINE 286840000DRIVER, PROSTHESIS58 reports
- SKYLINE 186850016APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY12 reports
- SKYLINE 186850014APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY11 reports
- SKYLINE 186862014APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY6 reports
- SKYLINE 186850018APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY5 reports
- SKYLINE 186802030APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY3 reports
- SKYLINE 186802032APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY3 reports
- SKYLINE 186802034APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 death3 reports
- SKYLINE 186860016APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY3 reports
- SKYLINE 186860018APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY3 reports
- SKYLINE 186801014APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- SKYLINE 186801016APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- SKYLINE 186801026APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- SKYLINE 186801030APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- SKYLINE 186803048APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- SKYLINE 186803066APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- SKYLINE 186850012APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- SKYLINE 186850015APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- SKYLINE 186852012APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- SKYLINE 186801012APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- SKYLINE 186801022APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- SKYLINE 186801028APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- SKYLINE 186802036APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- SKYLINE 186802040APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- SKYLINE 186802042APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- SKYLINE 186803051APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- SKYLINE 186803057APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- SKYLINE 186804064APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- SKYLINE 186852016APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- SKYLINE 186860017APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- SKYLINE 186862012APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- SKYLINE 186862018APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- SKYLINE 286820300TAP, BONE1 report
- SKYLINE 186801018SAppliance, fixation, spinal intervertebral body1 report
- SKYLINE 186802028SAppliance, fixation, spinal intervertebral body1 report
- SKYLINE 186803060SAppliance, fixation, spinal intervertebral body1 report
- SKYLINE 186850018SAppliance, fixation, spinal intervertebral body1 report
- SKYLINE 186862018SAppliance, fixation, spinal intervertebral body1 report
Recent SKYLINE adverse event reports
The 15 most recent reports across all models, 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 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 ↗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 23862562 ↗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 ↗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 ↗
Other Medos International Sàrl products
- TRUESPAN ORTHOCORD6 models · 4,109 reports
- FMS39 models · 3,588 reports
- EXPEDIUM291 models · 3,312 reports
- EXPEDIUM VERSE90 models · 2,686 reports
- EXPRESSEW6 models · 2,459 reports
- OMNISPAN ORTHOCORD3 models · 1,581 reports
- HEALIX ADVANCE ORTHOCORD21 models · 1,311 reports
- PROWLER SELECT9 models · 1,066 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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