SYMPHONY 1020-15-083SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034520780), received between Mar 8, 2024 and Dec 23, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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.

• MalfunctionDec 23, 2024Material Twisted/Bent; Mechanical Jam; Material Twisted/Bent; Mechanical Jam

  IT WAS REPORTED THAT THIS WAS A REOPERATION VIA PCF FOR OPLL. IN THE PREVIOUS SURGERY, SYNAPSE PRODUCTS WERE IMPLANTED INTO C4-TH1. IN THIS REOPERATION, SYMPHONY PRODUCTS WERE IMPLANTED INTO C1 AND C2, AND EXTENSION OF FUSION UPWARD WAS DONE. THE SET SCREW IN THE CONNECTION PART OF THE PARALLEL CONNECTOR WAS FOUND TO BE CROSS-THREADED WHEN THE PRODUCT WAS OPENED. THE SET SCREW IN THE CONNECTION PART WAS ATTEMPTED TO BE MOVED BUT COULD NOT BE MOVED AT ALL, AND THE PARALLEL CONNECTOR IN QUESTION WAS JUDGED TO BE UNUSABLE FOR C3. ANOTHER IMPLANT WAS USED. THERE WAS NO IMPACT ON THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. NO OTHER MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21005386 ↗
• MalfunctionMar 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A POSTERIOR CERVICAL FUSION (C2-TH3) PERFORMED ON (B)(6) 2018. THE DETAILS OF THE PRODUCTS USED IN THE INITIAL SURGERY ARE UNKNOWN. AFTER THE SURGERY, DURING FOLLOW-UP, NEUROLOGICAL SYMPTOMS WERE OBSERVED. THE EXTENSION SURGERY WAS PERFORMED ON (B)(6) 2024, DUE TO C1 CERVICAL SPONDYLOSIS. THE DISCECTOMY WAS PERFORMED AND AN OCCIPITAL PLATE, RODS, AND CONNECTORS WERE ADDED, AND AN EXTENSION PROCEDURE WAS PERFORMED TO CONNECT THE RODS TO THE RODS FROM A PREVIOUS FUSION. IN THE SURGERY, WHEN THE CONNECTOR IN QUESTION WAS REMOVED FROM THE STERILE BAG, THE SCREW OF THE CONNECTOR WAS LOOSE, AND THE MOMENTUM OF OPENING THE BAG CAUSED THE SCREW TO BECOME FILTHY. SINCE THE PRODUCT IN QUESTION COULD NOT BE USED, A SPARE PRODUCT WAS USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS PC IS RELATED TO PC-001548170 WHICH REPORTS THE INITIAL SURGERY AND THE EXTENSION SURGERY DUE TO C1 CERVICAL SPONDYLOSIS. THIS PC REPORTS THE EVENT OCCURRED IN THE EXTENSION SURGERY PERFORMED ON (B)(6) 2024. THIS REPORT IS FOR SYMPHONY OCT SYSTEM PARALLEL ROD CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18865736 ↗