SYMPHONY 2020-00-407Recalls & reported problems

Summary

The FDA's MAUDE database contains 103 adverse event reports that list this exact device (DI 10705034532806), received between Jun 22, 2020 and Sep 17, 2026 — classified as 1 injury, 102 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (86 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 25 most recent of 103 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50810298 ↗
• MalfunctionJun 29, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE SCREWDRIVER TIP STRIPPED ON TWO SCREWDRIVERS WHEN SURGEON WAS TIGHTENING THE SCREWS. AN ALTERNATIVE DEVICE FROM A CONSIGNED SET WAS USED TO FURTHER THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25655745 ↗
• MalfunctionApr 30, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE TIPS OF THE SET SCREWS GROUND DURING SURGERY. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25043407 ↗
• MalfunctionApr 30, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE TIPS OF THE SET SCREWS GROUND DURING SURGERY. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25043393 ↗
• 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 24884644 ↗
• 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 24883766 ↗
• MalfunctionApr 15, 2026Material Twisted/Bent

  IT WAS REPORTED MULTIPLE SCREWDRIVER 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 24883759 ↗
• MalfunctionApr 15, 2026Material Twisted/Bent

  IT WAS REPORTED MULTIPLE SCREWDRIVER 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 24883742 ↗
• MalfunctionApr 14, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE FINAL TIGHTENER WAS STRIPPED. SURGICAL DELAY WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24873177 ↗
• MalfunctionMar 24, 2026Device-Device Incompatibility

  IT WAS REPORTED THE X15 SELF RETAINING DOES NOT RETAIN AND THE X15 FINAL TIGHTENER TIP WAS DISTORTED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. ANOTHER INSTRUMENT WAS AVAILABLE. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681125 ↗
• MalfunctionMar 19, 2026Material Twisted/Bent

  IT WAS REPORTED THAT FRENCH ROD BENDER 3.5 AND 4.0, X15 SELF RETAINING INSERTER, AND X15 DRIVER FINAL TIGHTENER WERE INVOLVED IN AN INTRAOPERATIVE EVENT. THE REPORTED FAILURES INCLUDED INSTRUMENTS THAT HAD STRIPPED DUE TO WEAR AND TEAR, REQUIRING REPLACEMENT, AND A SPRING ON THE ROD CUTTER THAT HAD BROKEN FROM REPEATED USE. AS A RESULT, MULTIPLE SETS NEEDED TO BE OPENED TO FIND ALTERNATE INSTRUMENTS, AND THE AFFECTED SETS WERE REMOVED FROM USE UNTIL REPLACEMENTS COULD BE PROVIDED. THE SURGERY WAS MINIMALLY PROLONGED BY APPROXIMATELY 10 MINUTES, BUT THERE WAS NO CONSEQUENCE OR IMPACT TO THE PATIENT, AND NO OBSERVABLE CLINICAL SYMPTOMS WERE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24641257 ↗
• MalfunctionMar 19, 2026Material Twisted/Bent

  IT WAS REPORTED THAT FRENCH ROD BENDER 3.5 AND 4.0, X15 SELF RETAINING INSERTER, AND X15 DRIVER FINAL TIGHTENER WERE INVOLVED IN AN INTRAOPERATIVE EVENT. THE REPORTED FAILURES INCLUDED INSTRUMENTS THAT HAD STRIPPED DUE TO WEAR AND TEAR, REQUIRING REPLACEMENT, AND A SPRING ON THE ROD CUTTER THAT HAD BROKEN FROM REPEATED USE. AS A RESULT, MULTIPLE SETS NEEDED TO BE OPENED TO FIND ALTERNATE INSTRUMENTS, AND THE AFFECTED SETS WERE REMOVED FROM USE UNTIL REPLACEMENTS COULD BE PROVIDED. THE SURGERY WAS MINIMALLY PROLONGED BY APPROXIMATELY 10 MINUTES, BUT THERE WAS NO CONSEQUENCE OR IMPACT TO THE PATIENT, AND NO OBSERVABLE CLINICAL SYMPTOMS WERE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24641252 ↗
• MalfunctionMar 19, 2026Material Twisted/Bent

  IT WAS REPORTED THAT FRENCH ROD BENDER 3.5 AND 4.0, X15 SELF RETAINING INSERTER, AND X15 DRIVER FINAL TIGHTENER WERE INVOLVED IN AN INTRAOPERATIVE EVENT. THE REPORTED FAILURES INCLUDED INSTRUMENTS THAT HAD STRIPPED DUE TO WEAR AND TEAR, REQUIRING REPLACEMENT, AND A SPRING ON THE ROD CUTTER THAT HAD BROKEN FROM REPEATED USE. AS A RESULT, MULTIPLE SETS NEEDED TO BE OPENED TO FIND ALTERNATE INSTRUMENTS, AND THE AFFECTED SETS WERE REMOVED FROM USE UNTIL REPLACEMENTS COULD BE PROVIDED. THE SURGERY WAS MINIMALLY PROLONGED BY APPROXIMATELY 10 MINUTES, BUT THERE WAS NO CONSEQUENCE OR IMPACT TO THE PATIENT, AND NO OBSERVABLE CLINICAL SYMPTOMS WERE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24641250 ↗
• MalfunctionMar 19, 2026Material Twisted/Bent

  IT WAS REPORTED THAT FRENCH ROD BENDER 3.5 AND 4.0, X15 SELF RETAINING INSERTER, AND X15 DRIVER FINAL TIGHTENER WERE INVOLVED IN AN INTRAOPERATIVE EVENT. THE REPORTED FAILURES INCLUDED INSTRUMENTS THAT HAD STRIPPED DUE TO WEAR AND TEAR, REQUIRING REPLACEMENT, AND A SPRING ON THE ROD CUTTER THAT HAD BROKEN FROM REPEATED USE. AS A RESULT, MULTIPLE SETS NEEDED TO BE OPENED TO FIND ALTERNATE INSTRUMENTS, AND THE AFFECTED SETS WERE REMOVED FROM USE UNTIL REPLACEMENTS COULD BE PROVIDED. THE SURGERY WAS MINIMALLY PROLONGED BY APPROXIMATELY 10 MINUTES, BUT THERE WAS NO CONSEQUENCE OR IMPACT TO THE PATIENT, AND NO OBSERVABLE CLINICAL SYMPTOMS WERE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24641216 ↗
• MalfunctionMar 3, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE X15 DRIVER SHAFT STRIPPED DURING SET SCREW INSERTION. NO SHARDS WERE GENERATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24500300 ↗
• MalfunctionJan 14, 2026Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SET SCREW DRIVER WAS STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24071498 ↗
• MalfunctionDec 15, 2025Material Twisted/Bent; Material Twisted/Bent

  SCREWDRIVER SHAFTS ARE STRIPPED AND NOT SELF RETAINING SET SCREWS. THERE WAS NO PATIENT HARM. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810238 ↗
• MalfunctionDec 15, 2025Material Twisted/Bent; Material Twisted/Bent

  SCREWDRIVER SHAFTS ARE STRIPPED AND NOT SELF RETAINING SET SCREWS. THERE WAS NO PATIENT HARM. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810229 ↗
• MalfunctionDec 15, 2025Material Twisted/Bent; Material Twisted/Bent

  SCREWDRIVER SHAFTS ARE STRIPPED AND NOT SELF RETAINING SET SCREWS. THERE WAS NO PATIENT HARM. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810226 ↗
• MalfunctionDec 15, 2025Material Twisted/Bent; Material Twisted/Bent

  SCREW DRIVER SHAFTS ARE STRIPPED AND NOT SELF RETAINING SET SCREWS. THERE WAS NO PATIENT HARM. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810225 ↗
• MalfunctionDec 15, 2025Material Twisted/Bent; Material Twisted/Bent

  SCREW DRIVER SHAFTS ARE STRIPPED AND NOT SELF RETAINING SET SCREWS. THERE WAS NO PATIENT HARM. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810224 ↗
• MalfunctionDec 15, 2025Material Twisted/Bent; Material Twisted/Bent

  SCREWDRIVER SHAFTS ARE STRIPPED AND NOT SELF RETAINING SET SCREWS. THERE WAS NO PATIENT HARM. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810218 ↗
• MalfunctionOct 29, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THERE WAS A WORN TIP ON THE X15 FINAL TIGHTENER SHAFT, AND THERE WAS A CHINK/DENT IN THE PROBE INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23416232 ↗
• MalfunctionOct 15, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE. WHILE PLACING SET SCREWS IN ON TOP OF THE ROD, ONE OF THE SET SCREWS WAS CROSS THREADED AND THE REGISTRAR CONTINUED TO TRY AND ADVANCE THE SET SCREW, CAUSING IT TO STRIP THE TOP OF THE SET SCREW DRIVER. TWO SET SCREW DRIVERS ARE ON THE SET, SO THE OTHER ONE WAS USED. ALL WAS FINE IN THE END WITH NO COMPLICATIONS. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23283143 ↗
• MalfunctionSep 9, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED STATES THAT, " IT WAS PULLED FROM THE SET AND DISCARDED. THE DAMAGE IS A RESULT OF CHRONIC USAGE AND REGULAR WEAR AND TEAR, NOT A SPECIFIC ACUTE EVENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23010433 ↗