SYMPHONY 2020-00-118Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034530406), received between Dec 22, 2021 and Feb 8, 2024 — classified as 3 malfunctions.

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

• MalfunctionFeb 8, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A POSTERIOR FUSION (C3) FOR AXIAL FRACTURE ON (B)(6) 2024. IN THE SURGERY, WHEN USING BRAINLAB'S NAVIGATION SYSTEM TO INSERT A CAN SCREW, THE NAV SLEEVE IN QUESTION DID NOT SPIN, THE SCREW ATTACHED TO THE TIP LOOSENED, AND THE SCREW CAME OFF THE AXIS OF THE TIP OF THE SCREWDRIVER. FIRST, WHEN THE SCREW WAS INSERTED, THE NAV SLEEVE MADE A CLATTERING SOUND AND PROCEEDED. AT THAT POINT, THE POLY SCREW DRIVER RETEN SLEEVE AND THE NAV SLEEVE MOVED SEPARATELY AND THE SCREW DID NOT LOOSEN. AS THE SCREW WAS PROCEEDED, THE CLATTERING SOUND STOPPED AND THE POLY SCREW DRIVER RETEN SLEEVE AND THE NAV SLEEVE WERE INTEGRATED. AS THE SURGEON CONTINUED TO PROCEED, THE SCREW ATTACHED TO THE TIP CAME LOOSE. HE RETIGHTENED THE IMPLANT RIGIDLY AND REPLACED THE NAV SLEEVE, BUT IT STILL CAME LOOSE. IT WAS THEN EXTRACTED ONCE USING A NON-NAVIGATIONAL SCREWDRIVER. THE SCREW WAS REINSERTED USING THE NORMAL HOLLOW SCREWDRIVER AGAIN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) C1 ALIGNMENT AND NAV SLEEVE THIS IS REPORT 1 OF

  Patient problems: Insufficient Information

  MAUDE report 18669798 ↗
• MalfunctionFeb 8, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A POSTERIOR FUSION (C3) FOR AXIAL FRACTURE ON (B)(6) 2024. IN THE SURGERY, WHEN USING BRAINLAB'S NAVIGATION SYSTEM TO INSERT A CAN SCREW, THE NAV SLEEVE IN QUESTION DID NOT SPIN, THE SCREW ATTACHED TO THE TIP LOOSENED, AND THE SCREW CAME OFF THE AXIS OF THE TIP OF THE SCREWDRIVER. FIRST, WHEN THE SCREW WAS INSERTED, THE NAV SLEEVE MADE A CLATTERING SOUND AND PROCEEDED. AT THAT POINT, THE POLY SCREW DRIVER RETEN SLEEVE AND THE NAV SLEEVE MOVED SEPARATELY AND THE SCREW DID NOT LOOSEN. AS THE SCREW WAS PROCEEDED, THE CLATTERING SOUND STOPPED AND THE POLY SCREW DRIVER RETEN SLEEVE AND THE NAV SLEEVE WERE INTEGRATED. AS THE SURGEON CONTINUED TO PROCEED, THE SCREW ATTACHED TO THE TIP CAME LOOSE. HE RETIGHTENED THE IMPLANT RIGIDLY AND REPLACED THE NAV SLEEVE, BUT IT STILL CAME LOOSE. IT WAS THEN EXTRACTED ONCE USING A NON-NAVIGATIONAL SCREWDRIVER. THE SCREW WAS REINSERTED USING THE NORMAL HOLLOW SCREWDRIVER AGAIN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) C1 ALIGNMENT AND NAV SLEEVE THIS IS REPORT 2 OF

  Patient problems: Insufficient Information

  MAUDE report 18669796 ↗
• MalfunctionDec 22, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THE C1 ALIGNMENT AND NAV SLEEVE TOUCHES THE SOFT TISSUES DURING INSERTION AND THEREFORE CANNOT TURN. THE SCREW IS LOOSENED BY THE SCREWDRIVER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) C1 ALIGNMENT AND NAV SLEEVE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13063263 ↗