SYMPHONY 1020-24-003SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034520216), received between Jan 27, 2023 and Nov 8, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 8, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT THE SURGEON HAD REQUESTED A ROD TO ROD CROSS CONNECTOR FOR THE SYMPHONY POSTERIOR CERVICAL SYSTEM. THE SCRUB NURSE INADVERTENTLY DISASSEMBLED THE CONNECTOR, AND WHEN SHE CHOSE THE NEXT SIZE, THE SAME THING HAPPENED. THE THIRD (3RD) CONNECTOR WAS CHOSEN, BUT THIS TIME, THE SET SCREW APPEARED TO BE UNMOVABLE. THE SURGEON SUBSEQUENTLY DECIDED NOT TO USE A CONNECTOR. THIS WAS NOT BECAUSE OF THE ISSUES THAT HAD OCCURRED. THE IMPLANTS WERE NOT USED, AND THE SURGEON HAD ALSO DECIDED NOT TO USE THE IMPLANTS. THEY WERE "DAMAGED OR DISASSEMBLED" PRIOR TO HIS DECISION. NO FRAGMENTS WERE GENERATED. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. OTHER INFORMATION: SURGEON HAD DECIDED THAT HE DID NOT WANT TO USE A ROD TO ROD CONNECTOR. THERE WERE NO PATIENT OUTCOMES OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) CROSSCONN R2R 32 TO 35MM. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18093661 ↗
• MalfunctionMar 28, 2023Device-Device Incompatibility; Device-Device Incompatibility

  THE CROSS CONNECTOR WAS REPLACED WITH A NEW PRODUCT OF THE SAME PRODUCT CODE TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16629587 ↗
• InjuryJan 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINAL FUSION FOR DEGENERATIVE DISEASE ON (B)(6) 2022. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. AFTER THE SURGERY, THE CROSS-LINK WAS REMOVED DUE TO PRESSURE ULCER. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE, AND IT WAS REPORTED THAT THERE WAS NO ADVERSE CONSEQUENCE THAT AFFECTED THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SYMPHONY OCT SYSTEM CROSSCONNECTOR ROD TO ROD 32 TO 35MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Pocket Erosion

  MAUDE report 16252414 ↗