SYMPHONY 2020-33-400Recalls & reported problems
Medos International Sàrl · SYMPHONY OCT SYSTEM POLYAXIAL SCREW DRIVER SHAFT X20 · Class 2
All models of SYMPHONY (113)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Medos Symphony screwdriver shaft used in spine surgery has 94 reports, all describing malfunctions, with no deaths and no injuries. Common reports describe screwdriver tips wearing out so screws do not hold, shafts bending, and sleeves and shafts not fitting together. Reports fell from 40 in the prior 12 months to 6 in the latest 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 95
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 95 adverse event reports that list this exact device (DI 10705034530994), received between Jan 24, 2020 and Sep 15, 2026 — classified as 95 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (45 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.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility45
- Material Twisted/Bent44
- Material Deformation10
- Mechanical Problem4
- Break2
- Device Slipped1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions86
- No Consequences Or Impact To Patient8
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 95 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781555 ↗MalfunctionSep 15, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781548 ↗MalfunctionApr 15, 2026Material Twisted/Bent
IT WAS REPORTED MULTIPLE SCREWDRIVER TIPS HAVE BEEN WORN OUT, MAKING IT DIFFICULT TO USE. NO PATIENT IMPACTED. NO PATIENT HARM AND NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24883635 ↗MalfunctionApr 15, 2026Material Twisted/Bent
IT WAS REPORTED MULTIPLE SCREW DRIVER TIPS HAVE BEEN WORN OUT MAKING IT DIFFICULT TO USE. NO PATIENT IMPACTED. NO PATIENT HARM AND NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24883604 ↗MalfunctionApr 15, 2026Material Twisted/Bent
IT WAS REPORTED MULTIPLE SCREWDRIVER TIPS HAVE BEEN WORN OUT, MAKING IT DIFFICULT TO USE. NO PATIENT IMPACTED. NO PATIENT HARM AND NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24883576 ↗MalfunctionApr 3, 2026Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THE TIP OF THE SHAFT IS WORN OUT, SCREW DOESN'T HOLD. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24779662 ↗MalfunctionNov 12, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SCREWDRIVER SLEEVE AND SHAFT CAN NOT BE INSERTED TOGETHER. EVENT OCCURRED DURING SURGICAL SET UP. PROCEDURE WAS COMPLETED WITH NO IMPACT AS A BACK UP DEVICE WAS USED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23535025 ↗MalfunctionSep 18, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT X20 SHAFT BENT, WILL NOT SLIDE THRU SLEEVE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23085534 ↗MalfunctionSep 18, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT X20 SHAFT BENT, WILL NOT SLIDE THRU SLEEVE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23085224 ↗MalfunctionSep 18, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT X20 SHAFT BENT, WILL NOT SLIDE THRU SLEEVE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23085008 ↗MalfunctionSep 9, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT TWO OF THE SCREWDRIVERS ON THE SYMPHONY SET ARE DISENGAGING FROM THE SCREWDRIVERS DUE TO THE SCREWDRIVER TIPS BEING WORN. THE INSTRUMENT DID NOT BREAK INTO TWO OR MORE PIECES. THIS CAUSED A SLIGHT DELAY IN OPERATING TIME AS WE HAD TO OPEN ANOTHER KIT BUT DID NOT HAVE ANY ADVERSE EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23007374 ↗MalfunctionSep 9, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT TWO OF THE SCREWDRIVERS ON THE SYMPHONY SET ARE DISENGAGING FROM THE SCREWDRIVERS DUE TO THE SCREWDRIVER TIPS BEING WORN. THE INSTRUMENT DID NOT BREAK INTO TWO OR MORE PIECES. THIS CAUSED A SLIGHT DELAY IN OPERATING TIME AS WE HAD TO OPEN ANOTHER KIT BUT DID NOT HAVE ANY ADVERSE EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23007363 ↗MalfunctionJul 9, 2025Break; Break
IT WAS REPORTED THAT PATIENT UNDERWENT SPINAL FUSION ON (B)(6) 2025. THE TIP OF THE DRIVER BROKE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22461196 ↗MalfunctionJul 9, 2025Break; Break
IT WAS REPORTED THAT PATIENT UNDERWENT SPINAL FUSION ON (B)(6) 2025. THE TIP OF THE DRIVER BROKE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22461193 ↗MalfunctionJul 8, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE NURSE WAS ASSEMBLING THE SYMPHONY POLYAXIAL SCREWDRIVER AND SHE WAS HAVING DIFFICULTIES PUTTING THE SLEEVE ONTO THE SCREWDRIVER SHAFT. THIS IS DUE TO THE FACT THAT THE SHAFT IS SLIGHTLY BENT. THE NURSE SIMPLY TOOK THE OTHER DRIVER FROM THE SET. NO IMPACT ON PATIENT AND NO IMPACT ON TIME OF SURGERY, PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22440050 ↗MalfunctionJun 10, 2025Material Deformation; Material Deformation
IT WAS REPORTED THE SYMPHONY SHAFTS ARE SLIGHTLY BENT AND THE NURSING STAFF IS HAVING ISSUES LOADING THE POLYAXIAL SCREWDRIVER. THE PATIENT WAS NOT IMPACTED AND THERE WAS NO SURGICAL DELAY. PROCEDURE COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22177526 ↗MalfunctionApr 4, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON UNKNOWN DATE THE DRIVERS STRIPPED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21775293 ↗MalfunctionApr 4, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON UNKNOWN DATE THE DRIVERS STRIPPED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21775235 ↗MalfunctionApr 4, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON UNKNOWN DATE THE DRIVERS STRIPPED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21775221 ↗MalfunctionApr 4, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON UNKNOWN DATE THE DRIVERS STRIPPED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21775206 ↗MalfunctionApr 4, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON UNKNOWN DATE THE DRIVERS STRIPPED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21775198 ↗MalfunctionApr 4, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON UNKNOWN DATE THE DRIVERS STRIPPED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21775180 ↗MalfunctionApr 4, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON UNKNOWN DATE THE DRIVERS STRIPPED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21775163 ↗MalfunctionApr 4, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON UNKNOWN DATE THE DRIVERS STRIPPED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21775151 ↗MalfunctionApr 4, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON UNKNOWN DATE THE DRIVERS STRIPPED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21775139 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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