SYMPHONY 2020-22-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034532608), received between Feb 8, 2023 and Feb 8, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 8, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THIS WAS A POSTERIOR CERVICAL FUSION AND A LAMINOPLASTY (C1 RIGHT LATERAL MASS) FOR THE CERVICAL SPONDYLOTIC MYELOPATHY ON (B)(6) 2023. AFTER C1/2 FUSION, BRAINLAB¿S ROBOT AND NAVIGATION WERE USED TO CREATE HOLES FOR SCREW INSERTION. THEN, THE GUIDE WIRE WAS MANUALLY INSERTED. AFTER THE GUIDE WIRE WERE INSERTED INTO FOUR HOLES, THE HOLLOW TAP AND THE SCREWS WERE INSERTED THROUGH THE GUIDE WIRE. DURING SCREW INSERTION ON THE RIGHT SIDE OF C1, THE SCREW TAP WAS REPEATEDLY MOVED IN AND OUT FOR DIRECTIONAL ADJUSTMENT SEVERAL TIMES. WHEN THE GUIDE WIRE WAS REMOVED AFTER SCREW INSERTION, THE IMAGE SHOWED THAT GUIDE WIRE-LIKE OF APPROXIMATELY 5 MM TO 1 CM. IT WAS CONFIRMED THAT THE GUIDE WIRE WAS BROKEN AND REMAINED IN THE BODY. REMOVAL WAS IMPOSSIBLE DUE TO THE POSITION OF THE GUIDE WIRE, AND THE MATERIAL OF THE GUIDE WIRE WAS NITINOL. THEREFORE, THE SURGEON DECIDED NOT TO REMOVE THE GUIDE WIRE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE SURGEON CONFIRMED BY X-RAY THAT THE BROKEN GUIDE WIRE REMAINED IN THE BODY. ACCORDING TO THE SURGEON, THE GUIDE WIRE IS FOR CERVICAL VERTEBRAE AND IS THIN. IN ADDITION, THE GUIDE WIRE WAS BROKEN DUE TO THE

  Patient problems: Foreign Body In Patient

  MAUDE report 16327255 ↗