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SYMPHONY 1020-40-130Recalls & reported problems

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

All models of SYMPHONY (113)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034512327), received between Jul 17, 2020 and Jul 17, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • Failure of Implant1
  • No Code Available1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 17, 2020Break; Break

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS A BROKEN T1 SCREW IN A PATIENT. THE ORIGINAL C3-T1 POSTERIOR CERVICAL FUSION SURGERY WAS PERFORMED ON AN UNKNOWN DATE. THE SYMPHONY 4.0X30 MM SCREW BROKE IN RIGHT T1 ABOUT MIDWAY THROUGH THE SHAFT. REVISION SURGERY WAS REQUIRED TO REMOVE SCREW. THE SURGEON REMOVED PARTIAL SCREW AND EXTENDED FUSION TO T3. THE PROCEDURE OUTCOME IS UNKNOWN. THERE WAS PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN RODS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ), UNKNOWN SET SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 4.0 PLY SCRW 4.0X30. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: Failure of Implant; No Code Available

    MAUDE report 10289011 ↗

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Sources and updates

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