SYMPHONY 2020-00-244Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034530758), received between Sep 13, 2022 and Sep 19, 2023 — classified as 3 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.

• MalfunctionSep 19, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 DURING A POSTERIOR CERVICAL FUSION (C1-C2) FOR CERVICAL MYELOPATHY PROCEDURE, A NURSE ASSEMBLED NECESSARY INSTRUMENTS INCLUDING THE DRILL GUIDE BODY ACCORDING TO PROCEDURE MANUALS. DURING THE DISASSEMBLING THE DRILL GUIDE BODY AFTER FINISHING THE FINAL FIXATION, WHEN ATTEMPTING TO SEPARATE THE DRILL GUIDE SLEEVE FROM THE DRILL GUIDE GRADUATION ADJUSTMENT PORTION, THE WELDING ON THE DRILL STOPPER PORTION PEELED OFF AND THE DRILL GUIDE GRADUATION ADJUSTMENT PORTION WAS DAMAGED. THE DRILL GUIDE BODY HAD BEEN READY BUT NOT BEEN USED IN THE SURGERY, THEREFORE THERE WAS NO IMPACT ON THE PATIENT NOR THE SURGICAL TIME. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) ADJ DRILL GUIDE BODY 2.8MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17775011 ↗
• MalfunctionSep 13, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A POSTERIOR CERVICAL FUSION PERFORMED ON (B)(6) 2022. THE NURSE ASSEMBLED THE NAVIGATION DRILL GUIDE BODY IN QUESTION, BUT THE SILVER KNOB PART WAS PUSHED DOWN WHILE THE SCALE OF THE DRILL GUIDE WAS NOT SET TO "A". SO, THE DOCTOR PUSHED THE SILVER KNOB IN TO MAKE AN ADJUSTMENT, THEN INSTRUMENTS GOT STUCK WHERE IT SHOULDN'T HAVE BEEN. THE NAVIGATION DRILL GUIDE BODY COULD NO LONGER BE DISASSEMBLED. THERE WAS NO SURGICAL DELAY. NO FRAGMENTS WAS REPORTED. PATIENT STATUS/ OUTCOME? :STABLE NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) ADJ DRILL GUIDE BODY 2.8MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15411650 ↗
• MalfunctionSep 13, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A POSTERIOR CERVICAL FUSION PERFORMED ON (B)(6) 2022. THE NURSE ASSEMBLED THE NAVIGATION DRILL GUIDE BODY IN QUESTION, BUT THE SILVER KNOB PART WAS PUSHED DOWN WHILE THE SCALE OF THE DRILL GUIDE WAS NOT SET TO "A". SO, THE DOCTOR PUSHED THE SILVER KNOB IN TO MAKE AN ADJUSTMENT, THEN INSTRUMENTS GOT STUCK WHERE IT SHOULDN'T HAVE BEEN. THE NAVIGATION DRILL GUIDE BODY COULD NO LONGER BE DISASSEMBLED. THERE WAS NO SURGICAL DELAY. NO FRAGMENTS WAS REPORTED. PATIENT STATUS/ OUTCOME? :STABLE NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) ADJ DRILL GUIDE BODY 2.8MM THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15411649 ↗