SYMPHONY 1020-35-128SRecalls & reported problems
Medos International Sàrl · SYMPHONY OCT SYSTEM POLYAXIAL SCREW diameter 4.0 Rod, 3.5X28mm 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034524443), received between May 22, 2024 and May 22, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Slipped” (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.
Reports received per month
Most reported problems
Device problems
- Device Slipped2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 22, 2024Device Slipped; Device Slipped
IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY (C1-2) PERFORMED ON (B)(6) 2024, WITH THE SCREWS IN QUESTION. AFTER THE SURGERY, ON AN UNKNOWN DATE, LOOSENING OF THE SCREWS ON C2 WERE CONFIRMED. THE REVISION SURGERY IS SCHEDULED ON (B)(6) 2024. THE LOOSENED SCREWS WILL BE REMOVED, AND THE EXTENSION SURGERY (C3~C4) WILL BE PERFORMED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 4.0 PLY SCRW 3.5X28 THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Patient problems: Insufficient Information
MAUDE report 19377185 ↗InjuryMay 22, 2024Device Slipped; Device Slipped
IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY (C1-2) PERFORMED ON (B)(6) 2024, WITH THE SCREWS IN QUESTION. AFTER THE SURGERY, ON AN UNKNOWN DATE, LOOSENING OF THE SCREWS ON C2 WERE CONFIRMED. THE REVISION SURGERY IS SCHEDULED ON (B)(6) 2024. THE LOOSENED SCREWS WILL BE REMOVED, AND THE EXTENSION SURGERY (C3~C4) WILL BE PERFORMED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 4.0 PLY SCRW 3.5X28 THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Patient problems: Insufficient Information
MAUDE report 19377177 ↗
Other Posterior cervical screw system devices
- INFINITY™ Occipitocervical Upper Thoracic System 3604026Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation2 recalls1 report
- CONNECTOR 79-2003Orthofix US LLC · Posterior cervical screw system1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 360PT4022Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- CONNECTOR 79-2002Orthofix US LLC · Posterior cervical screw system1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 3604532Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 3604024Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- OASYS 48551000Stryker Corporation · Orthosis, cervical pedicle screw spinal fixation45 reports
- YUKON OCT Spinal System 7601-05030VB Spine LLC · Orthosis, cervical pedicle screw spinal fixation15 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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