SYMPHONY 1020-45-110SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034521879), received between Mar 21, 2022 and Jun 9, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration” (1 report).

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.

• InjuryJun 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A POSTERIOR FUSION (C5-6) FOR TREATING CERVICAL INJURY ON (B)(6) 2022, WHILE A SCREW WAS BEING INSERTED AT C5, THE BONE BROKE. THE SURGEON ABANDONED THE ATTEMPT TO DEPLOY A SCREW ON THE RIGHT LESION. ONLY A FUSION ON THE LEFT SIDE WAS ACCOMPLISHED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. PATIENT WAS STABLE. THIS REPORT IS FOR A 4.0 PLY SCRW 4.5X10. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 14649632 ↗
• InjuryMar 21, 2022Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A SPINAL FUSION (DECOMPRESSION) FOR TREATING SPINAL CANAL STENOSIS ON (B)(6) 2022. THE SCREW IN QUESTION WAS DEPLOYED AT C3 RIGHT, AND THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. ON AN UNKNOWN DATE IT WAS FOUND THAT THE SCREW IN QUESTION HAD BACKED OUT. THE PATIENT IS SCHEDULED TO UNDERGO A REVISION PROCEDURE ON (B)(6) 2022. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 4.0 PLY SCRW 4.5X10. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13840993 ↗