SYMPHONY 1020-74-220SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034523637), received between Jun 14, 2022 and Jul 14, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Migration” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2022Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A SPINAL FUSION IN THE CERVICAL SPINE FOR TREATING TRAUMA ON (B)(6) 2022. TORQUE WAS NOT APPLIED TO THE SCREW ON THE ROD¿S HINGE DURING FINAL SCREW TIGHTENING. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. IT WAS POSTOPERATIVELY FOUND THAT THE ROD HAD BEEN LOOSE. IT WAS CONFIRMED THAT THE EVENT HAD NOT BEEN TRIGGERED BY ANY PRODUCT DEFECTIVENESS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) TI 4.0-4.0X220 ADJ ROD. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15013479 ↗
• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: ON (B)(6) 2021, A PATIENT UNDERWENT A PRIMARY POSTERIOR CERVICAL FUSION IN THE OCCIPITAL BONE AND THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. ON (B)(6) 2022, THE SURGEON REPORTED THAT THE ROD MIGHT HAVE COME OFF, AND A REVISION PROCEDURE WAS SCHEDULED FOR (B)(6) 2022. IT WAS REPORTED THAT DURING THE REVISION PROCEDURE ON (B)(6) 2022, THE SURGEON COMMENTED THAT THE SETSCREWS ON BOTH ENDS OF THE PLATE HAD COME OFF, AND THAT THE ROD WAS ABOUT TO PROTRUDE FROM THE OCCIPITAL REGION. THIS REPORT IS FOR A SYMPHONY OCT SYSTEM ADJUSTABLE ROD TITANIUM ALLOY DIAMETER 4.0 TO 4.0X220MM. THIS IS REPORT 1 OF 2 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Drug Resistant Bacterial Infection

  MAUDE report 14690183 ↗
• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: ON (B)(6) 2021, A PATIENT UNDERWENT A PRIMARY POSTERIOR CERVICAL FUSION IN THE OCCIPITAL BONE AND THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. ON (B)(6) 2022, THE SURGEON REPORTED THAT THE ROD MIGHT HAVE COME OFF, AND A REVISION PROCEDURE WAS SCHEDULED FOR (B)(6) 2022. IT WAS REPORTED THAT DURING THE REVISION PROCEDURE ON (B)(6) 2022, THE SURGEON COMMENTED THAT THE SETSCREWS ON BOTH ENDS OF THE PLATE HAD COME OFF, AND THAT THE ROD WAS ABOUT TO PROTRUDE FROM THE OCCIPITAL REGION. THIS REPORT IS FOR A SYMPHONY OCT SYSTEM ADJUSTABLE ROD TITANIUM ALLOY DIAMETER 4.0 TO 4.0X220MM. THIS IS REPORT 2 OF 2 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Drug Resistant Bacterial Infection

  MAUDE report 14690094 ↗