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SYMPHONY 1020-35-130Recalls & reported problems

Medos International Sàrl · SYMPHONY OCT SYSTEM POLYAXIAL SCREW Diameter 4.0 Rod, 3.5X30mm · Class 2 · Implant

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 10705034508771), received between Apr 13, 2022 and Apr 13, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device-Device Incompatibility1

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.

  • MalfunctionApr 13, 2022Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED ON AN UNKNOWN DATE, DURING POSTERIOR SPINAL FUSION C1-C2 PROCEDURE, THE SURGEON DESCRIBED HAVING DIFFICULTY STARTING THE SCREW DESPITE HAVING TAPPED WITH A 3.5 DIAMETER TAP. THE TIP OF THE SCREW WAS NOT ENGAGING AND ONLY AFTER TAPPING WITH A 4.0 DIAMETER TAP, THE SURGEON WAS ABLE TO INSERT THE 3.5MM DIAMETER SCREW TO ENGAGE WITH THE BONE. PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 4.0 PLY SCRW 3.5X30 THIS IS REPORT 3 OF 3 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14102709 ↗

Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices

All APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.