SYMPHONY 1020-35-728Recalls & reported problems
Medos International Sàrl · SYMPHONY OCT SYSTEM SHAFT POLYAXIAL SCREW Diameter 4.0 Rod, 3.5X28mm · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034513690), received between Jan 21, 2020 and Jan 21, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 21, 2020Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE C1 SCREWS WERE BREAKING WHERE THE THREAD MEETS THE SMOOTH SHANK. THIS WAS DISCOVERED VIA X-RAY. THE SCREWS REMAIN IMPLANTED AND NO REVISION PROCEDURE IS CURRENTLY SCHEDULED. THERE ARE NO KNOWN PATIENT CONSEQUENCES. THIS REPORT IS FOR A SYMPHONY 4.0 SHAFT POLY SCREW 3.5X28. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9611537 ↗MalfunctionJan 21, 2020Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE C1 SCREWS WERE BREAKING WHERE THE THREAD MEETS THE SMOOTH SHANK. THIS WAS DISCOVERED VIA X-RAY. THE SCREWS REMAIN IMPLANTED AND NO REVISION PROCEDURE IS CURRENTLY SCHEDULED. THERE ARE NO KNOWN PATIENT CONSEQUENCES. THIS REPORT IS FOR A SYMPHONY 4.0 SHAFT POLY SCREW 3.5X28. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9611499 ↗
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 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page