SYMPHONY 3010-19-011Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705034561646), received between Jan 29, 2024 and Apr 15, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2026Material Twisted/Bent

  IT WAS REPORTED MULTIPLE SCREW DRIVER TIPS HAVE BEEN WORN OUT MAKING IT DIFFICULT TO USE. NO PATIENT IMPACTED. NO PATIENT HARM AND NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24884183 ↗
• MalfunctionApr 15, 2026Material Twisted/Bent

  IT WAS REPORTED MULTIPLE SCREW DRIVER TIPS HAVE BEEN WORN OUT MAKING IT DIFFICULT TO USE. NO PATIENT IMPACTED. NO PATIENT HARM AND NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24884163 ↗
• MalfunctionSep 23, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING THE CASE HE SURGEON WAS USING THE INSTRUMENT TO DRIVE A SCREW INTO THE PEDICLE OF THE UPPER THORACIC REGION. THE SURGEON END UP STRIPPING THE ONE DRIVER DURING THE PROCESS OF DRIVING THE SCREW IN, A NEW DRIVE WAS THEN ELECTED. IN THE SAME SURGERY, WHEN ATTEMPTING TO DRIVER A SCREW IN FURTHER, THE DRIVE STRIPED ONCE AGAIN. THE PATIENT WAS NOT HARMED AND THE SURGERY WAS STILL EXECUTED AS PLANNED. THERE WAS NO SURGICAL DELAY. THE FRAGMENTS WERE NOT GENERATED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20280429 ↗
• MalfunctionSep 20, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING A POSTERIOR CASE, A SURGEON WAS USING THE INSTRUMENT TO DRIVE A SCREW INTO THE PEDICLE. WHILE DRIVING THE SCREW, THE SURGEON STRIPPED ONE OF THE DRIVERS. THE DRIVER WAS CONSIDERED UNUSABLE THERE AFTER AND A NEW DRIVER WAS USED TO FINISH THE SURGERY. THE PATIENT WAS NOT HARMED AND THE SURGERY WAS STILL EXECUTED AS PLANNED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20266910 ↗
• MalfunctionSep 20, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING THE CASE HE SURGEON WAS USING THE INSTRUMENT TO DRIVE A SCREW INTO THE PEDICLE OF THE UPPER THORACIC REGION. THE SURGEON END UP STRIPPING THE ONE DRIVER DURING THE PROCESS OF DRIVING THE SCREW IN, A NEW DRIVE WAS THEN ELECTED. IN THE SAME SURGERY, WHEN ATTEMPTING TO DRIVER A SCREW IN FURTHER, THE DRIVE STRIPED ONCE AGAIN. THE PATIENT WAS NOT HARMED AND THE SURGERY WAS STILL EXECUTED AS PLANNED. THERE WAS NO SURGICAL DELAY. THE FRAGMENTS WERE NOT GENERATED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20266874 ↗
• MalfunctionSep 20, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING THE CASE HE SURGEON WAS USING THE INSTRUMENT TO DRIVE A SCREW INTO THE PEDICLE OF THE UPPER THORACIC REGION. THE SURGEON END UP STRIPPING THE ONE DRIVER DURING THE PROCESS OF DRIVING THE SCREW IN, A NEW DRIVE WAS THEN ELECTED. IN THE SAME SURGERY, WHEN ATTEMPTING TO DRIVER A SCREW IN FURTHER, THE DRIVE STRIPED ONCE AGAIN. THE PATIENT WAS NOT HARMED AND THE SURGERY WAS STILL EXECUTED AS PLANNED. THERE WAS NO SURGICAL DELAY. THE FRAGMENTS WERE NOT GENERATED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20266836 ↗
• MalfunctionSep 9, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THAT ON AN UNKNOWN DATE THE SLEEVE GOT STUCK OVER THE SCREW. TO REMOVE THE SCREW, IT WAS NEEDED TO BREAK THE SLEEVE. IN THE PROCESS OF BREAKING THE SLEEVES, THE DRIVER BROKE AND THE THREADED TIP GOT STUCK IN THE SHAFT OF THE SCREW. BOTH ARE NOW BROKEN. PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) SYMPHONY NAV DRIVER - SLEEVE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20177323 ↗
• MalfunctionJan 29, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THIS WAS A POSTERIOR CERVICAL FUSION (C5 RIGHT) FOR CERVICAL SPONDYLOTIC MYELOPATHY ON JAN. 11, 2024. IN THE SURGERY, SYMPHONY WAS USED. AFTER INSERTING PVFS INTO C5R, THE SCREW IN QUESTION AND THE SCREWDRIVER SHAFT IN QUESTION ARE NO LONGER COMING OFF. THE SCREW WAS REMOVED BY MOVING IT SLIGHTLY AND APPLYING A PULLING FORCE. THE SURGEON AND THE NURSE COULD NOT REMOVE THEM OUTSIDE THE BODY. A SPARE DRIVER SHAFT WAS USED AND A NEW SCREW WAS OPENED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY. THIS REPORT IS FOR ONE (1) SYMPH NAV DRIVER - SHAFT X20 THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18602392 ↗