SYMPHONY 2020-00-138Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034530543), received between Apr 23, 2020 and May 13, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ON (B)(6) 2020, THE COUNTER TORQUE WAS CONTINUALLY STICKING ON THE TULIPS OF THE SCREWS WHILE SURGEON WAS FINAL TIGHTENING TO COMPLETE THE CASE. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES: SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN) THIS REPORT IS FOR A COUNTER TORQUE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10053507 ↗
• MalfunctionApr 23, 2020Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SYMPHONY TORQUE LIMITING HANDLE ¿WOULDN¿T POP¿ WHEN TIGHTENING SET SCREWS, SURGEON MENTIONED THAT 3.0 MM PRESSURE IS TOO MUCH FOR THIS PROCEDURE. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - SET SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9992508 ↗