EXPEDIUM ALTALYNE VIPER 1797-96-300SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034566481), received between Jan 25, 2024 and Jan 25, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Jam” (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 18, 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.

• MalfunctionJan 25, 2024Mechanical Jam; Mechanical Jam

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY FOR ADOLESCENT IDIOPATHIC SCOLIOSIS PERFORMED ON (B)(6) 2024. IN THE SURGERY, ALTALYNE WAS USED FOR BOTH SIDE. THE SURGEON USED THE ROD CUTTER IN QUESTION TO CUT THE ROD IN QUESTION. THE ROD WAS NOT CUT WHERE INTENDED AND THE ROD WAS NOT LONG ENOUGH. HE OR SHE TRIED TO MAKE ANOTHER ROD WITH THE REMAINING END, AND WHEN HE OR SHE CUT IT JUST SHORT OF THE HEX, THE CUT LINE WAS APPLIED AT THE HEX AND THE ROD BENT AND COULD NOT BE CUT PROPERLY. HE OR SHE THEN MANAGED TO CUT THAT ROD, BUT IT WAS NOT LONG ENOUGH, SO THE SURGEON OPENED A NEW ROD. THE SURGEON TRIED TO CUT THE NEW ROD AGAIN WITH THE ROD CUTTER, BUT IT GOT STUCK AND COULD NOT BE CUT. THE SURGEON OPENED THE NEW ROD AGAIN AND CUT IT WITH THE MM TABLE ROD CUTTER THAT THE HOSPITAL KEPT AS A SPARE. AFTER ROD ROTATION AND KYPHOSIS FORMATION, THE ROD WAS STRETCHED AND THE LENGTH OF THE OTHER ROD WAS NOT LONG ENOUGH, SO ANOTHER ROD WAS OPENED. PATIENT STATUS/ OUTCOME: STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) ALTALYNE ULTRA 5.5 X 300MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT: (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18578836 ↗