SYMPHONY 2020-00-141Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705034530574), received between Sep 29, 2021 and Aug 8, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SCREWS ON THE REDUCER TOWER COULD NOT BE REMOVED. IT WAS CONFIRMED AT THE DISTRIBUTION CENTER ON (B)(6) 2025. THIS IS NOT INVOLVED IN THE SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22755384 ↗
• MalfunctionMar 13, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING A SPINAL FUSION FOR SPONDYLOLISTHESIS OF THE CERVICAL SPINE, THE SURGEON ATTACHED THE REDUCER TOWER, DROPPED A ROD IN, AND TRIED TO PUT A SET SCREW INSERTER INTO THE REDUCER TOWER, BUT THE SET SCREW INSERTER GOT STUCK HALFWAY AND IT WOULD NOT GO IN EASILY. THE SAME PHENOMENON OCCURRED WITH THE OTHER REDUCER TOWER IN THE INSTRUMENT SET. WHEN THE 2 REDUCER TOWERS WERE CHECKED AFTER SURGERY, THE TIPS OF THOSE 2 REDUCER TOWERS WERE BENT INWARD, WHICH IS THOUGHT TO BE THE CAUSE OF THE EVENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. NO OTHER MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21592611 ↗
• MalfunctionMar 13, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING A SPINAL FUSION FOR SPONDYLOLISTHESIS OF THE CERVICAL SPINE, THE SURGEON ATTACHED THE REDUCER TOWER, DROPPED A ROD IN, AND TRIED TO PUT A SET SCREW INSERTER INTO THE REDUCER TOWER, BUT THE SET SCREW INSERTER GOT STUCK HALFWAY AND IT WOULD NOT GO IN EASILY. THE SAME PHENOMENON OCCURRED WITH THE OTHER REDUCER TOWER IN THE INSTRUMENT SET. WHEN THE 2 REDUCER TOWERS WERE CHECKED AFTER SURGERY, THE TIPS OF THOSE 2 REDUCER TOWERS WERE BENT INWARD, WHICH IS THOUGHT TO BE THE CAUSE OF THE EVENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. NO OTHER MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21592609 ↗
• MalfunctionAug 22, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. THE SURGEON WAS HAVING TROUBLE ATTACHING THE REDUCER TO THE READ OF THE SCREWS. AFTER TRYING FOR SOME TIME, THEY MANAGED AND ACHIEVED THE ROD REDUCTION REQUIRED. WHEN THEY HANDED THE INSTRUMENT OUT, IT WAS APPARENT THAT THE MIDDLE PORTION OF THE INSTRUMENT WAS BENT. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A REDUCER TOWER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20039965 ↗
• MalfunctionApr 11, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED DURING A TRAINING SESSION THE KIT WAS DELIVERED BROKEN AND NEVER USED FOR PROCEDURES. IT IS UNKNOWN WHEN THE KIT BROKE. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE SYMPHONY OCT SYSTEM REDUCER TOWER FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19086614 ↗
• MalfunctionJul 12, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE DEVICES WONT UN TWIST. THIS REPORT IS FOR ONE SYMPHONY OCT SYSTEM REDUCER TOWER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17309320 ↗
• MalfunctionJul 12, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE DEVICES WONT UN TWIST. THIS REPORT IS FOR ONE (1) SYMPHONY OCT SYSTEM REDUCER TOWER. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17309236 ↗
• MalfunctionApr 17, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON UNKNOWN DATE, AT THE END OF THE CASE, THE TOWER REDUCER COULD NOT BE SEPARATED. IT WAS MADE SEPARATED USING AN INSTRUMENT MILK, BUT IT IS STILL BINDING WHEN IT WAS PUT TOGETHER. THERE WAS NO ADVERSE EVENT. THERE WAS NO REQUIREMENT OF REVISION SURGERY. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) REDUCER TOWER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16755164 ↗
• MalfunctionSep 29, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT, THE MODULE SET WERE CROSS-THREADED. THE REDUCER TOWER MODULE AND THE OTHER THAT GOES ON IT, WAS CROSS THREADED, WOULD NOT COME OFF. IT HAS NOT BEEN USED IN THE CASE AND WAS ORDERED TO KEEP ON THE SHELF FOR ANY CASES. THESE WERE CROSS-THREADED BEFORE THEY WERE EVER USED IN PROCEDURE. NO PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) SYMPHONY OCT SYSTEM REDUCER TOWER. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12546991 ↗
• MalfunctionSep 29, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT, THE MODULE SET WERE CROSS-THREADED. THE REDUCER TOWER MODULE AND THE OTHER THAT GOES ON IT, WAS CROSS THREADED, WOULD NOT COME OFF. IT HAS NOT BEEN USED IN THE CASE AND WAS ORDERED TO KEEP ON THE SHELF FOR ANY CASES. THESE WERE CROSS-THREADED BEFORE THEY WERE EVER USED IN PROCEDURE. NO PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) SYMPHONY OCT SYSTEM REDUCER TOWER. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12546988 ↗