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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 2 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

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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Sources and updates

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