SYMPHONY 1020-40-116Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034512259), received between Jan 11, 2021 and Nov 2, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 2, 2023Break; Break

  DEVICE REPORT FROM CHINA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 DURING POSTERIOR CERVICAL FUSION, THE SCREW IN QUESTION BROKE WHILE PARTIALLY IN THE PATIENT¿S BONE. THE SURGEON WAS ABLE TO REMOVE ALL FRAGMENTS OF THE BROKEN SCREW WITHOUT ANY ADDITIONAL MEDICAL INTERVENTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER SCREW OF THE SAME TYPE, THERE WAS A SURGICAL DELAY OF 2 HOURS. THERE WAS NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SYMPHONY OCT SYSTEM POLYAXIAL SCREW DIAMETER 4.0 ROD, 4.0X16MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18056238 ↗
• MalfunctionMar 13, 2023Break; Break

  IT WAS REPORTED THAT 4.0 ON AN (B)(6) 2023, DURING AN UNKNOWN PROCEDURE SYMPHONY SCREW BROKE DURING INSERTION IN A LATERAL MASS AT THE NECK OF THE SCREW. SHUKLA SCREW REMOVER SET WAS USED SUCCESSFULLY. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF 20-30 MINUTES. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 4.0 PLY SCRW 4.0X16. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16534046 ↗
• InjuryJan 11, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING C2-T2 POSTERIOR SPINAL FUSION SURGERY THE SURGEON WAS IMPLANTING C2 SCREW AND IT BROKE AT THE SHANK BENEATH TULIP HEAD. SURGEON DRILLED AND TAPPED WITH 3.0 TAP; SCREW BROKE AS SCREW HEAD GETTING FLUSH WITH BONE. PATIENT¿S BONE QUALITY WAS DESCRIBED AS MEDIUM. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. THERE WERE NO FRAGMENTS GENERATED. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY REMOVING THE SCREW SHANK FROM PEDICLE AND HAD TO BURR DOWN BONE TO REMOVE WITH VICE GRIPS. THERE WERE NO PATIENT CONSEQUENCES. CONCOMITANT DEVICE REPORTED: UNKNOWN DRILL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); UNKNOWN PROBE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) REAMER HEAD F/RIA 2 Ø10. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11148894 ↗