SYMPHONY 1020-35-312SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034527796), received between Jun 20, 2024 and Jun 20, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT A C5-C6 POSTERIOR FUSION USING THE SYMPHONY POSTERIOR CERVICAL SYSTEM. THE SURGEON OPTED TO USE THE LONG TAB SCREWS. THE PROCEDURE WENT SMOOTHLY, UNTIL PART OF THE FINAL STEP WHERE THE TABS HAVE TO BE REMOVED. THE SYMPHONY TAB BREAKER WAS AVAILABLE, BUT THERE WAS HUGE RESISTANCE TO THE TAB SNAPPING. AS THE SURGEON WAS APPLYING FORCE TO THE TAB BREAKER THE WHOLE CONSTRUCT AND NECK WERE VISIBLY TWISTING WITH HIS MOVEMENT. SURGEON SWAPPED TO USING A PAIR OF NIBBLERS. THE TAB STILL WERE RESISTANT TO SNAPPING. THE TABS WERE REMOVED BY USING A ROD HOLDER ON THE ROD IN SITU TO STABILISE WHILE FORCE WAS APPLIED TO SNAP THE TABS. IT WASN¿T IDEAL AND THE ROD WAS EXPOSED, AND SWOLLEN, SO THERE WAS A HUGE RISK TO FURTHER DAMAGE. THERE WAS NO REPORTED PATIENT COMPLICATIONS. PROCEDURE WAS COMPLETED WITH NO DELAY. THIS REPORT IS FOR A 4.0 CAN/RED SCRW 3.5X12. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19575109 ↗
• MalfunctionJun 20, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT A C5-C6 POSTERIOR FUSION USING THE SYMPHONY POSTERIOR CERVICAL SYSTEM. THE SURGEON OPTED TO USE THE LONG TAB SCREWS. THE PROCEDURE WENT SMOOTHLY, UNTIL PART OF THE FINAL STEP WHERE THE TABS HAVE TO BE REMOVED. THE SYMPHONY TAB BREAKER WAS AVAILABLE, BUT THERE WAS HUGE RESISTANCE TO THE TAB SNAPPING. AS THE SURGEON WAS APPLYING FORCE TO THE TAB BREAKER THE WHOLE CONSTRUCT AND NECK WERE VISIBLY TWISTING WITH HIS MOVEMENT. SURGEON SWAPPED TO USING A PAIR OF NIBBLERS. THE TAB STILL WERE RESISTANT TO SNAPPING. THE TABS WERE REMOVED BY USING A ROD HOLDER ON THE ROD IN SITU TO STABILISE WHILE FORCE WAS APPLIED TO SNAP THE TABS. IT WASN¿T IDEAL AND THE ROD WAS EXPOSED, AND SWOLLEN, SO THERE WAS A HUGE RISK TO FURTHER DAMAGE. THERE WAS NO REPORTED PATIENT COMPLICATIONS. PROCEDURE WAS COMPLETED WITH NO DELAY. THIS REPORT IS FOR A 4.0 CAN/RED SCRW 3.5X12. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19575094 ↗