SYMPHONY 1020-40-126SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034529042), received between Apr 10, 2024 and Apr 10, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Slipped” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2024Device Slipped; Migration; Device Slipped; Migration

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024 THE PATIENT UNDERWENT A POSTERIOR CERVICAL FUSION (C2-7) WITH THE SCREWS IN QUESTION. AFTER THE ORIGINAL PROCEDURE, ON (B)(6) 2024 IT WAS DISCOVERED THAT THERE WAS LOOSENING OF THE C7 PUNCTURE POINT. A REVISION PROCEDURE WAS SCHEDULED FOR (B)(6) 2024 TO REMOVE THE LOOSENED SCREWS AND RE-INSERT IN ANOTHER TRAJECTORY. THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY. C2-7 CROSSLINKS, SET SCREWS, AND RODS WERE REMOVED, AND C7 (RIGHT AND LEFT) SCREWS WERE REMOVED. ON THE LEFT SIDE OF C7, THE PUNCTURE POINT WAS CHANGED AND THE SCREW WAS REINSERTED. T1 AND T2, SCREWS WERE INSERTED ON RIGHT AND LEFT. THE ROD WAS PLACED ON C2 TO T2, AND CROSSLINK WAS PLACED TO TERMINATE THE SURGERY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SYMPHONY OCT SYSTEM POLYAXIAL SCREW DIAMETER 4.0 ROD, 4.0X26MM 3.5 AND 4.0. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19081288 ↗
• InjuryApr 10, 2024Device Slipped; Migration; Device Slipped; Migration

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024 THE PATIENT UNDERWENT A POSTERIOR CERVICAL FUSION (C2-7) WITH THE SCREWS IN QUESTION. AFTER THE ORIGINAL PROCEDURE, ON (B)(6) 2024 IT WAS DISCOVERED THAT THERE WAS LOOSENING OF THE C7 PUNCTURE POINT. A REVISION PROCEDURE WAS SCHEDULED FOR (B)(6) 2024 TO REMOVE THE LOOSENED SCREWS AND RE-INSERT IN ANOTHER TRAJECTORY. THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY. C2-7 CROSSLINKS, SET SCREWS, AND RODS WERE REMOVED, AND C7 (RIGHT AND LEFT) SCREWS WERE REMOVED. ON THE LEFT SIDE OF C7, THE PUNCTURE POINT WAS CHANGED AND THE SCREW WAS REINSERTED. T1 AND T2, SCREWS WERE INSERTED ON RIGHT AND LEFT. THE ROD WAS PLACED ON C2 TO T2, AND CROSSLINK WAS PLACED TO TERMINATE THE SURGERY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SYMPHONY OCT SYSTEM POLYAXIAL SCREW DIAMETER 4.0 ROD, 4.0X26MM 3.5 AND 4.0. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19081151 ↗