SYMPHONY 1020-35-116Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034508702), received between Jul 21, 2021 and Oct 10, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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. How this data works · Data updated Oct 13, 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.

• MalfunctionOct 10, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, A PATIENT UNDERWENT A PROCEDURE TO REMOVE BROKEN HARDWARE. DURING REMOVAL PROCEDURE IT WAS DISCOVERED THAT FIVE OF THE TEN SYMPHONY SCREWS HAD SHEARED OFF. THE SURGEON COULD NOT RETRIEVE THE BROKEN HALF OF THE SCREW AND IT WAS LEFT INSIDE THE PATIENT. THERE WAS NO SURGICAL DELAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 20420023 ↗
• MalfunctionOct 10, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, A PATIENT UNDERWENT A PROCEDURE TO REMOVE BROKEN HARDWARE. DURING REMOVAL PROCEDURE IT WAS DISCOVERED THAT FIVE OF THE TEN SYMPHONY SCREWS HAD SHEARED OFF. THE SURGEON COULD NOT RETRIEVE THE BROKEN HALF OF THE SCREW AND IT WAS LEFT INSIDE THE PATIENT. THERE WAS NO SURGICAL DELAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 20419971 ↗
• MalfunctionOct 10, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, A PATIENT UNDERWENT A PROCEDURE TO REMOVE BROKEN HARDWARE. DURING REMOVAL PROCEDURE IT WAS DISCOVERED THAT FIVE OF THE TEN SYMPHONY SCREWS HAD SHEARED OFF. THE SURGEON COULD NOT RETRIEVE THE BROKEN HALF OF THE SCREW AND IT WAS LEFT INSIDE THE PATIENT. THERE WAS NO SURGICAL DELAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 20419869 ↗
• MalfunctionMar 8, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6). 2023, DURING A C2-T2 SURGERY, THE SURGEON WAS PUTTING A ROD ONTO THE SCREW AND WAS MANIPULATING THE SYMPHONY TULIP WITH A HEAVY NEEDLE HOLDER. THE SURGEON NOTICED A PIECE OF METAL THAT LOOKED LIKE THREADING COMING OFF THE TULIP. AFTER THE SURGEON IMPLANTED BOTH OF THE RODS AND FINAL TIGHTENED, THE SURGEON REMOVED THE PIECE OF METAL FROM THE TULIP WITH FORCEPS. THERE WAS NO ADVERSE EVENT AS A RESULT OF THE INCIDENT. THERE WAS NO OTHER MEDICAL INTERVENTION REQUIRED. THIS REPORT INVOLVES ONE SYMPHONY OCT SYSTEM POLYAXIAL SCREW DIAMETER 4.0 ROD, 3.5X16MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16505570 ↗
• MalfunctionFeb 15, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING POSTERIOR SPINAL FUSION SURGERY WHILE INSERTING SCREW IN LATERAL MASS OF C4, THE SHAFT OF SCREW BROKE OFF IN THE BONE. THEY TRIED TO PUT NEW SCREW BESIDE BROKEN SCREW BUT IT DIDN¿T WORK. FRAGMENTS WERE GENERATED BUT WERE NOT REMOVED. THERE WAS A SURGICAL DELAY OF FIFTEEN (15) MINUTES. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES ONE (1) DEVICE 4.0 PLY SCRW 3.5X16. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4)..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13536191 ↗
• MalfunctionJul 21, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING POSTERIOR SPINAL FUSION SURGERY THERE WERE MULTIPLE ISSUES WHILE USING SYMPHONY. IT WAS NOTICED THAT THE SCREW HEAD CHIP WHEN A SET SCREW WAS APPARENTLY CROSS THREADED WHILE USING THE REDUCTION GUN. IT WAS UNKNOWN HOW IT OCCURRED . ALSO, THERE WERE TWO SET SCREW DRIVERS THAT HAD TIPS SHEARED OFF WHILE INSERTING SET SCREWS. FRAGMENTS WERE GENERATED AND EASILY REMOVED. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: UNKNOWN REDUCTION GUN (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN) THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) 4.0 PLY SCRW 3.5X16 THIS REPORT IS 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12203191 ↗