SYMPHONY 1020-40-134SRecalls & reported problems
Medos International Sàrl · SYMPHONY OCT SYSTEM POLYAXIAL SCREW diameter 4.0 Rod, 4.0X34mm 3.5 and 4.0 · Class 2 · Implant
All models of SYMPHONY (113)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034529080), received between May 6, 2024 and May 6, 2024 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2024, TO PERFORM EXTENSION OF SPINAL CONSTRUCT. THE CROSSLINK, AND ROD WERE REMOVED. C1 SCREW ON LEFT AND RIGHT WERE REMOVED. OCCIPITAL BONE PLATE WAS PLACED. RODS WERE PLACED ON OC-C2. THE CROSSLINK WAS PLACED, AND FINAL FUSION WAS PERFORMED. NO SCREW WAS INSERTED ON C3-4. THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT WAS STABLE. PATIENT ORIGINALLY UNDERWENT POSTERIOR CERVICAL FUSION (C1-2) ON (B)(6) 2023. THIS REPORT IS FOR A 4.0 PLY SCRW 4.0X34. THIS IS REPORT 2 OF 4 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 19255032 ↗
Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices
- EXPEDIUM 179702000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL439 reports
- EXPEDIUM VERSE 199721001Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL227 reports
- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- Arsenal Deformity Spinal Fixation System 47127Alphatec Spine, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL66 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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