SYMPHONY 1020-45-222SRecalls & reported problems
Medos International Sàrl · SYMPHONY OCT SYSTEM CORTICAL FIX POLYAXIAL SCREW diameter 4.0 Rod, 4.5X22mm 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034521732), received between Jun 26, 2025 and Jun 26, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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-Device Incompatibility2
- Difficult to Advance2
Patient problems
- Unspecified Tissue Injury2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 26, 2025Device-Device Incompatibility; Difficult to Advance; Device-Device Incompatibility; Difficult to Advance
IT WAS REPORTED THAT THE PATIENT UNDERWENT A CERVICAL AND THORACIC POSTERIOR FUSION (C7-TH2) FOR METASTASIS. IN THE SURGERY, SYMPHONY SCREW WAS USED FOR POSTERIOR CERVICAL AND THORACIC FIXATION AT C7-TH2 IN CASES OF TH1 METASTASIS OR INFECTION. HOWEVER, SINCE TH1 WAS A BIOPSY, NO SCREW INSERTION WAS PERFORMED. AFTER INSERTING A SYMPHONY SCREW IN QUESTION INTO C7 ON THE LEFT SIDE, THE SYMPHONY SCREW IN QUESTION AND SCREWDRIVER COULD NOT BE REMOVED. THE SURGEON REVERSED THE SLEEVE OF THE SCREWDRIVER ONLY, BUT THE SYMPHONY SCREW IN QUESTION DID NOT REMOVE. THE SURGEON REMOVED THE SYMPHONY SCREW IN QUESTION AS IT WAS BECAUSE OF THE RISK OF BACK-OUT IF HE TRIED TO FORCE IT OUT. THE SURGEON ATTEMPTED TO REMOVE THE SYMPHONY SCREW IN QUESTION AND SCREWDRIVER OUTSIDE THE SURGICAL FIELD BUT WAS UNABLE TO DO SO. THEREFORE, THE SURGEON USED A DIFFERENT SCREWDRIVER AND ANOTHER SYMPHONY SCREW OF THE SAME SIZE, BUT AGAIN THE SCREWDRIVER AND SCREW COULD NOT BE REMOVED. THE SURGEON CONFIRMED THAT THE SCREWDRIVER AND SCREW SETTINGS WERE FINE, BUT ONCE AGAIN REMOVED THE SCREW AS IT WAS. SO, THE SURGEON USED THE SAME SIZE REDUCTION CAN SCREW OVER THE GUIDEWIRE. THE REDUCTION CAN SCREW COULD BE REMOVED
Patient problems: Unspecified Tissue Injury
MAUDE report 22335071 ↗MalfunctionJun 26, 2025Device-Device Incompatibility; Difficult to Advance; Device-Device Incompatibility; Difficult to Advance
IT WAS REPORTED THAT THE PATIENT UNDERWENT A CERVICAL AND THORACIC POSTERIOR FUSION (C7-TH2) FOR METASTASIS. IN THE SURGERY, SYMPHONY SCREW WAS USED FOR POSTERIOR CERVICAL AND THORACIC FIXATION AT C7-TH2 IN CASES OF TH1 METASTASIS OR INFECTION. HOWEVER, SINCE TH1 WAS A BIOPSY, NO SCREW INSERTION WAS PERFORMED. AFTER INSERTING A SYMPHONY SCREW IN QUESTION INTO C7 ON THE LEFT SIDE, THE SYMPHONY SCREW IN QUESTION AND SCREWDRIVER COULD NOT BE REMOVED. THE SURGEON REVERSED THE SLEEVE OF THE SCREWDRIVER ONLY, BUT THE SYMPHONY SCREW IN QUESTION DID NOT REMOVE. THE SURGEON REMOVED THE SYMPHONY SCREW IN QUESTION AS IT WAS BECAUSE OF THE RISK OF BACK-OUT IF HE TRIED TO FORCE IT OUT. THE SURGEON ATTEMPTED TO REMOVE THE SYMPHONY SCREW IN QUESTION AND SCREWDRIVER OUTSIDE THE SURGICAL FIELD BUT WAS UNABLE TO DO SO. THEREFORE, THE SURGEON USED A DIFFERENT SCREWDRIVER AND ANOTHER SYMPHONY SCREW OF THE SAME SIZE, BUT AGAIN THE SCREWDRIVER AND SCREW COULD NOT BE REMOVED. THE SURGEON CONFIRMED THAT THE SCREWDRIVER AND SCREW SETTINGS WERE FINE, BUT ONCE AGAIN REMOVED THE SCREW AS IT WAS. SO, THE SURGEON USED THE SAME SIZE REDUCTION CAN SCREW OVER THE GUIDEWIRE. THE REDUCTION CAN SCREW COULD BE REMOVED
Patient problems: Unspecified Tissue Injury
MAUDE report 22335068 ↗
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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