SYMPHONY 1020-23-102SRecalls & reported problems
Medos International Sàrl · SYMPHONY OCT SYSTEM CROSSCONNECTOR HEAD TO HEAD 30 to 42mm · Class 2 · Implant
All models of SYMPHONY (113)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034520155), received between Jul 24, 2023 and Jul 9, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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 Incompatibility5
- Mechanical Jam2
- Material Deformation1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 9, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam
IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2025. DURING SURGERY, THE HOLE FOR PASSING THROUGH THE TALL SET SCREWS IN THE H2H CROSS CONNECTOR WAS NOT MOVE, SO THE CONNECTION COULD NOT BE MADE PROPERLY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22459658 ↗MalfunctionJul 9, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam
IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2025. DURING SURGERY, THE HOLE FOR PASSING THROUGH THE TALL SET SCREWS IN THE H2H CROSS CONNECTOR WAS NOT MOVE, SO THE CONNECTION COULD NOT BE MADE PROPERLY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22459623 ↗MalfunctionJul 22, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT THIS WAS A POSTERIOR CERVICAL FUSION (CERVICAL VERTEBRAE) ON (B)(6) 2024. DURING THE SURGERY, A TALL SET SCREWS ARE INSTALLED TO USE H TO H CROSSCONNECTOR. CROSS-THREADING OCCURRED WHEN THE PRODUCT WAS FITTED, NUT INSTALLED ON ONE SIDE AND NUT ON THE OTHER. THE SALES REP ASKED THE SURGEON TO REMOVE IT WITH THE INSERTER, BUT HE COULDN¿T. AT THIS POINT, THE CROSS-THREADED NUT WAS STUCK IN EITHER F OR R. SINCE IT DID NOT MOVE WHEN GRABBED WITH A PAIR OF TAPERED PLIERS, SURGEON GAVE UP TRYING TO REMOVE THE NUT. THE NUT ON THE PREVIOUSLY INSTALLED OPPOSITE SIDE WAS REMOVED, ONE SIDE WAS RELEASED, A TORQUE SCREWDRIVER WAS PLACED IN THE CORE OF THE TALL SET SCREW ON THE CROSS-THREADED SIDE, AND THE PRODUCT WAS HELD TO RELEASE THE TORQUE. THE ENTIRE BODY WAS REMOVED WITH THE NUT ATTACHED. RTOR WAS INSTALLED INSTEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES SURGICAL DELAY. PATIENT OUTCOME IS REPORTED AS STABLE.THIS REPORT IS FOR ONE (1) CROSSCONN H2H 30 TO 42MMTHIS IS REPORT 1 OF 1 FOR COMPLAINT PC-001640192
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19799449 ↗MalfunctionOct 19, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, WHEN THE CROSS CONNECTOR WAS BENT, THE MOVING PART BECAME UNABLE TO BE MOVED AND THE CROSS CONNECTOR WAS UNABLE TO BE INSERTED. THEREFORE, A NEW ONE WITH THE SAME SIZE WAS USED IN THE SURGERY, AND THE SURGEON CONFIRMED THERE WAS NO PROBLEMS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT OUTCOME IS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) CROSSCONN H2H 30 TO 42MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17966366 ↗MalfunctionJul 24, 2023Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A POSTERIOR CERVICAL FUSION (C3-6). THE PROCEDURE PROCEEDED AS PLANNED, AND FINAL TIGHTENING OF A ROD WAS COMPLETED. AFTER THAT, THE SURGEON PLANNED TO SET A CROSS CONNECTOR ONTO THE SCREW AT C5. THE CROSS CONNECTOR SELECTED DID NOT FIT INTO THE SET SCREW AT ALL, SO A NEW CROSS CONNECTOR OF ONE SIZE SMALLER WAS SELECTED. THE SMALLER SIZED CONNECTOR WOULD ALSO NOT FIT ONTO THE SET SCREW, SO A BENDER WAS USED TO STRETCH THE CURVED PART OF THE CROSS CONNECTOR. THIS MADE THE CONNECTOR UNUSABLE. ANOTHER CROSS CONNECTOR OF THE SMALLER SIZE WAS PREPARED AND USED. THIS CONNECTOR WAS SET AT THE PROPER POSITION AND FINAL TIGHTENED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH UNDER 30 MINUTES OF DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SYMPHONY OCT SYSTEM CROSSCONNECTOR HEAD TO HEAD 30 TO 42MM. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17380929 ↗
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- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- Arsenal Deformity Spinal Fixation System 47127Alphatec Spine, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL66 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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