SYMPHONY 1020-40-118SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034529004), received between Jan 9, 2023 and Oct 23, 2023 — classified as 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 18, 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.

• MalfunctionOct 23, 2023Break; Break

  DEVICE REPORT FROM SWITZERLAND REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, A SCREW BROKE WHEN BEING SCREWED INTO THE CORTICAL BONE. THE BONE WAS VERY HARD, AND WAS TAPPED BEFORE INSERTING THE SCREW. THE SCREW WAS ABLE TO BE REMOVED AND ANOTHER PUT IN. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TWENTY MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A 4.0 PLY SCRW 4.0X18. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17987384 ↗
• MalfunctionJan 9, 2023Break; Material Discolored; Entrapment of Device; Break; Material Discolored; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, SYMPHONY SPINE 4.0 X 18 LATERAL MASS SCREW SHANK SCREW UNDER TULIP HEAD SHEARED OFF WHILE BEING INSERTED INTO BONE. THE IMPLANT WAS TURQUOISE IN COLOR BUT THE NUMBERS WERE CORRECT ON THE IMPLANT. THE SHEARED OFF SCREW WAS SENT FOR EXAMINATION, THE OTHER TURQUOISE COLOR SCREW THAT WAS IN THE CADDY AND A MORE NORMAL COLORED 4.0 SCREW FOR COMPARISON. ALL HAVE THE SAME PRODUCT CODE. THERE WAS A SURGICAL DELAY OF 5 MINUTES. AN ATTEMPT TO REMOVE THE FRAGMENT, BUT, IT WAS EMBEDDED IN BONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 4.0 PLY SCRW 4.0X18. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16126582 ↗