SYMPHONY 1020-35-314SRecalls & reported problems
Medos International Sàrl · SYMPHONY OCT SYSTEM POLYAXIAL SCREW REDUCTION CANNULATED Diameter 4.0 Rod, 3.5X14mm 3.5 4.0 · Class 2 · Implant
All models of SYMPHONY (113)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034527802), received between Jul 25, 2025 and Jul 25, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Migration” (1 report).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 25, 2025Migration; Migration
IT WAS REPORTED THAT THIS WAS A CERVICAL AND THORACIC POSTERIOR FUSION (C2-T3) FOR CERVICAL-THORACIC KYPHOSIS ON (B)(6) 2025. IN THE SURGERY, AFTER THE FINAL FIXATION OF THE SCREWS AT C2-T3, THE SURGEON ATTEMPTED TO REMOVE THE TAB OF THE SYMPHONY CAN/RED SCRW IN QUESTION THAT HAD BEEN PLACED AT THE LEFT SIDE OF C4. AT THAT TIME, THE SCREW HEAD THEN MOVED SLIGHTLY, AND THE SURGEON TO TAKE SOME TIME TO REMOVE THE TAB. IT WAS DIFFICULT TO REMOVE THE TAB PROPERLY BECAUSE THE SCREW HEAD KEPT MOVING. THE SURGEON THEN PERFORMED ADDITIONAL PROCEDURES TO TIGHTEN THE SETSCREW WITH ANOTHER SCREWDRIVER, AND THE SCREW HEAD DID NOT MOVE, AND THE SURGEON WAS ABLE TO REMOVE THE TAB. ADDITIONALLY, THE SAME TYPE OF TABBED SCREWS WERE USED AT C2, C3 RIGHT, C4 RIGHT, C7, T1, T2, T3, BUT THE TABS WERE ABLE TO BE REMOVED WITHOUT PROBLEM. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22609221 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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