SYMPHONY 1020-24-004Recalls & reported problems
Medos International Sàrl · SYMPHONY OCT SYSTEM CROSSCONNECTOR ROD TO ROD 35 to 40mm · 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 10705034519067), received between Oct 13, 2020 and Oct 13, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Mechanical Jam” (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
- Mechanical Jam2
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.
MalfunctionOct 13, 2020Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020, THE SURGEON COULD NOT LOCK THE SYMPHONY R2R CROSSLINK. FINAL LOCKING DRIVING KEPT STRIPPING SCREWS AND TRIED TWO CROSS LINKS, BUT BOTH STRIPPED OUT. FRAGMENTS WERE GENERATED, AND EASILY REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY SWITCHING THE FINAL LOCKING DRIVER SHAFT. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A CROSSCONN R2R 35 TO 40MM. THIS IS REPORT 9 OF 9 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10671899 ↗MalfunctionOct 13, 2020Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020, THE SURGEON COULD NOT LOCK THE SYMPHONY R2R CROSSLINK. FINAL LOCKING DRIVING KEPT STRIPPING SCREWS, AND TRIED TWO CROSS LINKS, BUT BOTH STRIPPED OUT. FRAGMENTS WERE GENERATED AND EASILY REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY SWITCHING THE FINAL LOCKING DRIVER SHAFT. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A CROSSCONN R2R 35 TO 40MM. THIS IS REPORT 8 OF 9 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10671661 ↗
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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