SYMPHONY 1020-64-075Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034511887), received between Jan 14, 2021 and Jan 14, 2021 — classified as 2 deaths.

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

• DeathJan 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT (B)(6) 2020, DURING POSTERIOR CERVICAL FUSION SURGERY THE PATIENT DIED. THE DEPUY SYNTHES SPINE SYSTEM UTILIZED IN THIS PROCEDURE WAS THE SYMPHONY OCT SYSTEM. THE INSTRUMENTATION OF THE SYMPHONY SCREWS WAS UNEVENTFUL. THE SURGEON FIRST INSTRUMENTED C4-6 LATERAL MASSES, THEN C2 PARS, AND FINALLY T1 PEDICLES. ALL SCREW PLACEMENTS WERE CONFIRMED BY THE SURGEON WITH FLUOROSCOPY. THE SURGEON PROCEEDED TO PERFORM THE DECOMPRESSION WITH A C3-7 LAMINECTOMY. AFTERWARDS THE SURGEON CHANGED THE VECTOR OF THE PATIENTS HEAD TO RE-ALIGN THE SPINE AFTER DECOMPRESSION. APPROXIMATELY TEN (10) MINUTES AFTERWARDS HE BEGAN PREPARING TWO (2) 4.0MM RODS. PRIOR TO INSTRUMENTATION OF THE RODS, THE PATIENT BEGAN TO LOSE SENSORY NEUROMONITORING SIGNALS. APPROXIMATELY FIVE (5) MINUTES LATER THE PATIENT LOSES MOTOR SIGNALS AND LOW BLOOD PRESSURE. AT THIS MOMENT THERE IS AN URGENCY TO COMPLETE THE CONSTRUCT AND CLOSE THE PATIENT. THE SURGEON DECIDED TO USE 3.5MM RODS INSTEAD. ALL RODS AND SET SCREWS WERE IMPLANTED AND FINAL TIGHTENED AS INTENDED. THE PATIENT WENT INTO CARDIAC ARREST APPROXIMATELY 5 MINUTES INTO CLOSING. APPROXIMATELY 1 HOUR AFTERWARDS, TIME OF DEATH WAS ANNOUNCED. THERE W

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11170850 ↗
• DeathJan 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT (B)(6) 2020, DURING POSTERIOR CERVICAL FUSION SURGERY THE PATIENT DIED. THE DEPUY SYNTHES SPINE SYSTEM UTILIZED IN THIS PROCEDURE WAS THE SYMPHONY OCT SYSTEM. THE INSTRUMENTATION OF THE SYMPHONY SCREWS WAS UNEVENTFUL. THE SURGEON FIRST INSTRUMENTED C4-6 LATERAL MASSES, THEN C2 PARS, AND FINALLY T1 PEDICLES. ALL SCREW PLACEMENTS WERE CONFIRMED BY THE SURGEON WITH FLUOROSCOPY. THE SURGEON PROCEEDED TO PERFORM THE DECOMPRESSION WITH A C3-7 LAMINECTOMY. AFTERWARDS THE SURGEON CHANGED THE VECTOR OF THE PATIENT¿S HEAD TO RE-ALIGN THE SPINE AFTER DECOMPRESSION. APPROXIMATELY TEN (10) MINUTES AFTERWARDS HE BEGAN PREPARING TWO (2) 4.0 MM RODS. PRIOR TO INSTRUMENTATION OF THE RODS, THE PATIENT BEGAN TO LOSE SENSORY NEUROMONITORING SIGNALS. APPROXIMATELY FIVE (5) MINUTES LATER THE PATIENT LOSES MOTOR SIGNALS AND LOW BLOOD PRESSURE. AT THIS MOMENT THERE IS AN URGENCY TO COMPLETE THE CONSTRUCT AND CLOSE THE PATIENT. THE SURGEON DECIDED TO USE 3.5 MM RODS INSTEAD. ALL RODS AND SET SCREWS WERE IMPLANTED AND FINAL TIGHTENED AS INTENDED. THE PATIENT WENT INTO CARDIAC ARREST APPROXIMATELY 5 MINUTES INTO CLOSING. APPROXIMATELY 1 HOUR AFTERWARDS, TIME OF DEATH WAS ANNOUNCED. THERE

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11169920 ↗