SYMPHONY 1020-40-328SRecalls & reported problems
Medos International Sàrl · SYMPHONY OCT SYSTEM POLYAXIAL SCREW REDUCTION CANNULATED Diameter 4.0 Rod, 4.0X28mm 3.5 4.0 · Class 2 · Implant
All models of SYMPHONY (113)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034520872), received between Dec 6, 2022 and Dec 6, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (1 report).
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 18, 2026.
Most reported problems
Device problems
- Material Deformation1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 6, 2022Material Deformation; Scratched Material; Material Deformation; Scratched Material
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A POSTERIOR CERVICAL FUSION (C2 RIGHT) FOR A C2 FRACTURE ON (B)(6) 2022. THE SURGEON TRIED TO REMOVE THE TAB BEFORE INSERTION BECAUSE THE TAB WAS INTERFERED. WHEN THE SURGEON TRIED TO REMOVE THE TAB OF THE TAB SCREW WITH A TAB BREAKER, THE SCREW MOVED WITH THE TAB BREAKER, AND THE TAB COULD NOT BE REMOVED. THE SURGEON PUT THE SCREW IN THE HOLE BEHIND THE COUNTER OF THE H2H AND REMOVED THE TAB. THEN, THE SCREW THREADS WERE SCRATCHED AND BENT AT THE SCREW NECK. A NEW SCREW WAS USED INSTEAD OF THE TAB SCREW IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SYMPHONY OCT SYSTEM POLYAXIAL SCREW REDUCTION CANNULATED DIAMETER 4.0 ROD, 4.0X28MM 3.5 4.0. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15924248 ↗
Other Posterior cervical screw system devices
- INFINITY™ Occipitocervical Upper Thoracic System 3604026Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation2 recalls1 report
- CONNECTOR 79-2002Orthofix 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
- 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
- OASYS 48551000Stryker Corporation · Orthosis, cervical pedicle screw spinal fixation45 reports
- SYMPHONY 1020-35-112Medos International Sàrl · Posterior cervical screw system6 deaths15 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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