SYMPHONY 2020-00-119Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034530413), received between Mar 22, 2021 and Sep 22, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SPRING ON THE ADJUSTABLE DRILL GUIDE HAS BROKEN OFF AND IS NOT ABLE TO BE PROPERLY ASSEMBLED WITH THE LONG 3.2MM NAVIGATED SYMPHONY DRILL GUIDE. THE ISSUE OCCURRED DURING SETUP FOR A POSTERIOR SPINAL FUSION. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23109821 ↗
• MalfunctionFeb 3, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, AFTER CASE, WHILE ASSOCIATE WAS DISASSEMBLING INSTRUMENTS FOR CLEANING, THE SYMPHONY DRILL GUIDE HANDLE DISCONNECTED FROM BUTTON AND ASSOCIATED INTERNAL SHAFT. ASSOCIATE NOTED THE PROBLEM WHICH COULD NOT BE REMEDIED AND SET WAS SENT FOR WASH AND DECONTAMINATION. THERE WAS NO PATIENT INVOLVEMENT. PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) SYMPHONY OCT SYSTEM DRILL GUIDE MODULAR HANDLE THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13440089 ↗
• MalfunctionMay 10, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE , THE INSTRUMENT ROOM TECHNICIAN WAS ASSEMBLING THE DRILL GUIDE HANDLE AND THE INNER LOCKING SHAFT WOULD NOT LOCK INTO PLACE. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SYMPHONY OCT SYSTEM DRILL GUIDE MODULAR HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11797795 ↗
• MalfunctionApr 14, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SYMPHONY MODULAR DRILL GUIDE HANDLE, INTERNAL SPRING WAS BROKEN. THERE WERE NO PATIENT CONSEQUENCES. PROCEDURE OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) DRILL GUIDE MODULAR HANDLE. THIS REPORT IS 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11667865 ↗
• MalfunctionMar 22, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SYMPHONY MODULAR DRILL GUIDE HANDLE RELEASE MECHANISM WAS BROKEN. THERE WERE NO PATIENT CONSEQUENCES. PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT INVOLVES ONE (1) SYMPHONY OCT SYSTEM DRILL GUIDE MODULAR HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11542582 ↗