SYMPHONY 2020-00-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034532622), received between Aug 25, 2020 and Jul 31, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2025Corroded; Device-Device Incompatibility; Corroded; Device-Device Incompatibility

  IT WAS REPORTED THAT INTRA-OPERATIVELY BOTH THE AO HANDLE AND AO TORQUE NM HANDLE BECAME STUCK TO THEIR CORRESPONDING SCREWDRIVERS CAUSING A FOUR (4) MINUTE DELAY IN THE OPERATION TIME AS THE SCRUB NURSE COULD NOT REMOVE THEM, WE NOTICED A SMALL BIT OF RUST INSIDE THE HANDLES AND WOULD LIKE THEM REPLACED PLEASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22675418 ↗
• MalfunctionJan 9, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE; SET SCREW DRIVER STUCK IN HANDLE AND WILL NOT COME OUT. THERE WAS NO PATIENT CONSEQUENCES REPORTED. NO SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21117984 ↗
• MalfunctionAug 22, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT BEFORE SURGERY ON (B)(6) 2024, WHEN THE AO HANDLES IN QUESTION WERE CLEANED AND STERILIZED IN THE CENTRAL SUPPLY ROOM, A BLOOD-LIKE DIRT WAS FOUND ON THEM, AND THEIR USE WAS STOPPED. ANOTHER HANDLE WAS USED AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE SYMPHONY OCT SYSTEM AO HANDLE, SMALL WITH SWIVEL THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20042548 ↗
• MalfunctionJun 7, 2021Corroded; Device-Device Incompatibility; Corroded; Device-Device Incompatibility

  THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11950411 ↗
• MalfunctionJun 7, 2021Corroded; Device-Device Incompatibility; Corroded; Device-Device Incompatibility

  THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11950355 ↗
• InjuryAug 25, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020 THE SURGEON DOING A POSTERIOR CERVICAL FUSION, WHILE FINISHING UP THE CASE AND BEGINNING TO LOCK THE SYMPHONY RODS IN PLACE FROM C3-T1. NURSE HANDED THE FIRST SET SCREW DRIVER THE DRIVER SHAFT FELL FROM THE HANDLE THAT THE SURGEON WAS HOLDING AND LANDED IN THE INCISION ON THE BACK OF THE PATIENTS NECK LANDING DIRECTLY ON HIS SPINAL CORD WHICH WAS FULLY EXPOSED FROM THE LAMINECTOMY THAT WAS COMPLETED TO DECOMPRESS THE SPINAL CORD. INTRAOPERATIVE NEUROPHYSIOLOGIC MONITORING (IONM) OF THE PATIENT'S NEURO SIGNALS THROUGHOUT THE CASE RECORDED AN IMMEDIATE DEFICIT TO THAT AREA OF THE SPINAL CORD. MOTORS WERE PERFORMED REGULARLY THROUGHOUT THE REMAINDER OF THE CASE AND FEEDBACK WAS PROVIDED TO THE SURGEON THAT SIGNALS WERE IMPROVING TOWARD BASELINE LEVELS. PROCEDURE WAS COMPLETED WITH NO SURGICAL DELAY. THE PATIENT STATUS/OUTCOME IS UNKNOWN. CONCOMITANT DEVICES: UNKNOWN SETSCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN RODS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN HANDLE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) AO HANDLE SMALL W SWIVEL. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Injury; Nerve Damage

  MAUDE report 10450833 ↗