SYMPHONY 1020-24-004SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034520223), received between Mar 10, 2021 and Jul 1, 2024 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ON (B)(6) 2024, THE CASE WAS A CERVICAL POSTERIOR FUSION WITH SYMPHONY AND AFTER OPENING A CROSS CONNECTOR FROM THE SYMPHONY SYSTEM OUT OF THE STERILE PACKAGE, THE SURGEON WAS NOT ABLE TO TURN THE SCREWS OF THE DEVICE SO THAT IT COULD BE FIXED TO THE ROD. DUE TO THIS PROBLEM THEY HAD TO REOPEN ANOTHER DEVICE AND THAT ONE WAS IMPLANTED WITHOUT ANY PROBLEMS. THERE WAS NO CONSEQUENCE FOR THE PATIENT. THERE WAS A FEW MINUTES OF A SURGICAL DELAY. THIS REPORT INVOLVES ONE (1) SYMPHONY OCT SYSTEM CROSSCONNECTOR ROD TO ROD 35 TO 40MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19643032 ↗
• MalfunctionApr 2, 2024Mechanical Jam; Mechanical Jam

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024 DURING A POSTERIOR FUSION FOR MYELOPATHY, AFTER THE SURGEON FINISHED INSERTING SCREWS, HE TRIED TO INSTALL THE PRODUCT IN QUESTION, BUT THE SCREWS WERE VERY TIGHT. THE SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) CROSSCONN R2R 35 TO 40MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19029358 ↗
• 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 35 TO 40MM THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18093659 ↗
• MalfunctionJan 11, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A POSTERIOR CERVICAL FUSION FOR CERVICAL MYELOPATHY. WHEN THE SURGEON TRIED TO LOOSEN THE SCREW OF THE CROSS CONNECTOR, THE SCREW WAS TOO HARD AND DIDN¿T MOVE. THE SURGEON APPLIED CONSIDERABLE FORCE TO LOOSEN EVEN ONE THREAD, AND THE SCREW LOOSENED WITH ABOUT TWO THREADS OF FORCE. HOWEVER, THE LOWER PART OF THE CROSS CONNECTOR FELL OFF AT THE SAME TIME. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. USUALLY, THE CROSS CONNECTOR CAN BE EASILY LOOSENED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SYMPHONY OCT SYSTEM CROSSCONNECTOR ROD TO ROD 35 TO 40MM. THIS IS REPORT 1 OF 1 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16139838 ↗
• MalfunctionApr 25, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A POSTERIOR CERVICAL FUSION (PCF) ON (B)(6) 2022, WHEN THE SURGEON TRIED TO UNSCREW THE ATTACHED SETSCREW OF THE 1ST CROSS CONNECTOR, THE COMPONENTS OF THE APPLICATOR INNER SHAFT HAPPENED TO BE DISMANTLED. AS IT SEEMED DIFFICULT TO REASSEMBLE THE UNIT DURING THE PROCEDURE, A REPLACEMENT WAS PREPARED. BECAUSE THE SURGEON FOLLOWED THE SAME MANNER FOR UNSCREWING THE ATTACHED SCREW OF THE 2ND CROSS CONNECTOR, IT BECAME DISMANTLED AGAIN. ANOTHER REPLACEMENT WAS USED. THE PROCEDURE WAS COMPLETED WITH LESS THAN THIRTY MINUTES DELAY. PATIENT WAS STABLE. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE COMPONENTS WERE FALLEN APART AND ONE OF THE WAVE SPRINGS WAS OBSERVED TO BE MISSING. THIS REPORT IS FOR ONE (1) CROSSCONN R2R 35 TO 40MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14196470 ↗
• MalfunctionMar 10, 2021Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A POSTERIOR CERVICAL FUSION WITH DECOMPRESSION AT C7/T1, TREATING CERVICAL SPONDYLOTIC RADICULOPATHY, THE SCREWS WERE DIFFICULT TO TIGHTEN. IT WAS PREOPERATIVELY CONFIRMED THAT THREE SCREWS ON THE CROSS CONNECTER WERE LOOSE. THE SURGEON DEPLOYED THE CROSS CONNECTER AND TRIED TO TIGHTEN ONE OF THE SCREWS. THEN, THE SURGEON FELT THAT THE SCREW SEEMED STUCK DUE TO EXCESSIVE TORQUE. THE SCREW WAS REMOVED AND RETRIED, WHICH FAILED AGAIN. THE SURGEON TRIED TO TIGHTEN THE SCREWS AGAIN AND COMPLETED THE SCREW FIXATION. THIS REPORT INVOLVES ONE (1) SYMPHONY OCT SYSTEM CROSSCONNECTOR ROD TO ROD 35 TO 40MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11453002 ↗