SYMPHONY 2020-00-145Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034530581), received between Apr 22, 2021 and Apr 6, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Break

  IT WAS REPORTED THE OUTER RING OF THE SYMPHONY ROD BENDER BROKE OFF. THERE WAS NO PATIENT HARM OR SURGERY DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24789548 ↗
• MalfunctionMar 19, 2026Break

  IT WAS REPORTED THAT FRENCH ROD BENDER 3.5 AND 4.0, X15 SELF RETAINING INSERTER, AND X15 DRIVER FINAL TIGHTENER WERE INVOLVED IN AN INTRAOPERATIVE EVENT. THE REPORTED FAILURES INCLUDED INSTRUMENTS THAT HAD STRIPPED DUE TO WEAR AND TEAR, REQUIRING REPLACEMENT, AND A SPRING ON THE ROD CUTTER THAT HAD BROKEN FROM REPEATED USE. AS A RESULT, MULTIPLE SETS NEEDED TO BE OPENED TO FIND ALTERNATE INSTRUMENTS, AND THE AFFECTED SETS WERE REMOVED FROM USE UNTIL REPLACEMENTS COULD BE PROVIDED. THE SURGERY WAS MINIMALLY PROLONGED BY APPROXIMATELY 10 MINUTES, BUT THERE WAS NO CONSEQUENCE OR IMPACT TO THE PATIENT, AND NO OBSERVABLE CLINICAL SYMPTOMS WERE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24641180 ↗
• MalfunctionAug 26, 2024Break; Break

  IT WAS REPORTED THAT ON JUL 30, 2024 THE JOINTS ON ROD BENDER ARE BREAKING APART. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) FRENCH ROD BENDER 3.5 AND 4.0. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20072788 ↗
• MalfunctionApr 22, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE THE SYMPHONY FRENCH BENDER INNER KNOB BROKE OFF THE FRENCH BENDER. TH FRENCH BENDER LOST THE ABILITY TO HOLD ROD. THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT INVOLVES ONE (1) SYMPHONY OCT SYSTEM FRENCH ROD BENDER FOR 3.5MM AND 4.0MM RODS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11711477 ↗