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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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

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