SYMPHONY 2020-00-403Recalls & reported problems
Medos International Sàrl · SYMPHONY OCT SYSTEM X15 DRIVER FINAL TIGHTENER · Class 1
All models of SYMPHONY (113)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Medos Symphony final tightener is a driver tool used to tighten set screws in an implant system. All 163 of its adverse event reports are malfunctions, with no injuries and no deaths. Most describe the tool being bent, with some describing breaks, stripped screws, and worn tips. Most reports describe no clinical signs in patients. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 173
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 173 adverse event reports that list this exact device (DI 10705034532790), received between Dec 3, 2019 and Sep 29, 2026 — classified as 173 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (149 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.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent149
- Break27
- Device-Device Incompatibility17
- Material Deformation8
- Entrapment of Device3
- Mechanical Problem3
- Calibration Problem2
- Device Difficult to Maintain1
Patient problems
- No Clinical Signs, Symptoms or Conditions153
- Insufficient Information11
- No Consequences Or Impact To Patient7
- Foreign Body In Patient2
Recent adverse event reports
The 25 most recent of 173 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Material Twisted/Bent
It was reported that the X15 DRIVER FINAL TIGHTENER worn down
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929632 ↗MalfunctionSep 29, 2026Material Twisted/Bent
It was reported that the X15 DRIVER FINAL TIGHTENER worn down.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929630 ↗MalfunctionSep 29, 2026Material Twisted/Bent
It was reported that the X15 DRIVER FINAL TIGHTENER worn down.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929629 ↗MalfunctionSep 29, 2026Material Twisted/Bent
It was reported that the X15 DRIVER FINAL TIGHTENER worn down.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929628 ↗MalfunctionSep 22, 2026Break; Material Twisted/Bent
It was reported that the Symphony final tightener was stripped/broken. There was no patient harm or surgical delay.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50856166 ↗MalfunctionSep 8, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50677505 ↗MalfunctionAug 14, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50256683 ↗MalfunctionAug 14, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50256652 ↗MalfunctionAug 14, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50256643 ↗MalfunctionAug 14, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50256612 ↗MalfunctionJun 12, 2026Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE FINAL TIGHTENER STRIPPED AND DOES NOT ENGAGE IN SET SCREW. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25491286 ↗MalfunctionJun 5, 2026Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE, FINAL TIGHTENER STRIPPED. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25414448 ↗MalfunctionJun 5, 2026Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE, FINAL TIGHTENER STRIPPED. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25414437 ↗MalfunctionJun 5, 2026Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE, FINAL TIGHTENER STRIPPED. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25414435 ↗MalfunctionJun 5, 2026Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE, FINAL TIGHTENER STRIPPED. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25414187 ↗MalfunctionApr 27, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE INSTRUMENT WAS STRIPPED. THERE WAS NO SURGICAL DELAY. THERE WERE NO FRAGMENTS GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25003308 ↗MalfunctionApr 21, 2026Break; Material Twisted/Bent
IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2026. DURING THE SURGERY, THE DEVICE ENGAGED WITH THE SET SCREW BUT THE SCREW BECAME STRIPPED, PREVENTING FINAL TIGHTENING. IT APPEARED SLIGHTLY CHIPPED EVEN TO THE NAKED EYE. THERE WERE 2 OF THE SAME PRODUCTS, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY USING THESE PRODUCTS. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24942166 ↗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 24884714 ↗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 24883889 ↗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 24883886 ↗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 24883879 ↗MalfunctionMar 24, 2026Material Twisted/Bent
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 24674958 ↗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 24641322 ↗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 24641321 ↗MalfunctionMar 2, 2026Material Twisted/Bent
IT WAS REPORTED THAT DURING A C2-C5 POSTERIOR FUSION PROCEDURE THE DEVICE X15 DRIVER FINAL TIGHTENER STRIPPED AND FAILED TO FINAL TIGHTEN THE SET SCREWS. IT WAS REPLACED WITH ANOTHER FROM THE SET, ALLOWING THE OPERATION TO PROCEED WITHOUT INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24484065 ↗
Other DRIVER, PROSTHESIS devices
- ATTUNE 2544-01-005Depuy (Ireland) · DRIVER, PROSTHESIS1,383 reports
- EXPEDIUM VERSE 299704230Medos International Sàrl · DRIVER, PROSTHESIS875 reports
- NA 9200-10-029Depuy (Ireland) · DRIVER, PROSTHESIS745 reports
- MOSS 279712600Depuy Spine, LLC · DRIVER, PROSTHESIS706 reports
- NA 2598-07-440Depuy (Ireland) · DRIVER, PROSTHESIS665 reports
- NA 2598-07-570Depuy (Ireland) · DRIVER, PROSTHESIS505 reports
- VIPER 286745550Depuy Spine, LLC · DRIVER, PROSTHESIS263 reports
- SUMMIT 2570-05-100Depuy (Ireland) · DRIVER, PROSTHESIS225 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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