SYMPHONY 2020-33-401Recalls & reported problems
Medos International Sàrl · SYMPHONY OCT SYSTEM POLYAXIAL SCREW DRIVER SHAFT X20, CANNULATED · Class 2
All models of SYMPHONY (113)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034530987), received between Sep 11, 2023 and Feb 24, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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 Incompatibility3
- Material Deformation2
- Device Slipped1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 24, 2026Device Slipped
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE. WHEN ATTACHING THE SCREW DURING THE SURGERY, THE OUTER SLEEVE APPEARED TO SPIN FREELY. WHEN THE SURGEON ATTACHED IT AND TRIED TO INSERT THE SCREW, THE SCREW CONTINUED TO SPIN FREELY DURING INSERTION ONLY WHEN USING THE CORRESPONDING DRIVER AND OUTER SLEEVE. ANOTHER SET WORKED WITHOUT ANY ISSUES, SO THE SURGEON USED THOSE AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24433697 ↗MalfunctionJun 10, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE DRIVER AND RETENTION SLEEVE WERE NOT WORKING. DRIVER WAS GETTING CAUGHT IN RETENTION SLEEVE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22175165 ↗MalfunctionOct 16, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
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 DRIVER APPEARED TO BE BENT AND DISENGAGED FROM THE SCREW UPON ATTACHING. AN ALTERNATIVE INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A FIVE (5) MINUTES OF SURGICAL DELAY. THERE WAS NO PATIENT AND PROCEDURE IMPACT. THIS REPORT IS FOR ONE (1) POLY SCREW DRIVER SHFT X20 CAN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17943828 ↗MalfunctionSep 11, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT DURING PRE-OP ON (B)(6) 2023, THE DRIVER AND SLEEVE IN QUESTION WERE STICKING AND GETTING STUCK. THE DRIVER SHAFT WAS FOUND TO BE BENT, AND BURRS WERE FOUND INSIDE OF THE DRIVER SLEEVE. THE EVENT DID NOT OCCUR DURING STERILE PROCESSING, FIELD INSPECTION, NOR DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SYMPHONY OCT SYSTEM POLYAXIAL SCREW DRIVER SHAFT X20, CANNULATED. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17719190 ↗
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- Mazor X System TPL0059-06Mazor Robotics Ltd · Orthopedic Stereotaxic Instrument2 recalls2 deaths392 reports
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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