EXPEDIUM 179702635Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034064864), received between Nov 21, 2017 and Nov 9, 2022 — classified as 1 injury, 1 malfunction.

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. 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.

• MalfunctionNov 9, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A SPINAL FUSION FOR NEUROMUSCULAR SCOLIOSIS ON (B)(6) 2022. AFTER TEMPORARY FIXATION WITH SET SCREWS, THE PROCESS OF TEMPORARILY TIGHTENING AND LOOSENING WAS REPEATED IN ORDER TO APPLY COMPRESSION AND DISTRACTION OPERATIONS FOR ROD INSERTION. ALTHOUGH THE SURGEON FIXED THE ROD AND THE SET SCREW, THEY LOOSENED. THE SCREW HEAD MOVED ON THE ROD. THE SAME OPERATION WAS REPEATED SEVERAL TIMES. THEN, IT WAS CONFIRMED THAT THE THREADS INSIDE THE SCREW HEAD WERE BROKEN. THE SURGEON USED A REPLACEMENT SCREW, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A 30-MINUTE DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM MONOAXIAL SCREW 5.5 X 6 X 35MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15761527 ↗
• InjuryNov 21, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

  ON (B)(6) 2016, SURGERY FOR SCOLIOSIS WAS PERFORMED USING THE EXPEDIUM SYSTEM. THE FIXED AREA WAS T11 ¿ L4. RECENTLY, SURGEON CONFIRMED THROUGH AN X-RAY THAT SET SCREWS (PART#: UNK) FIXED AT CAUDAL END WERE LOOSENED AND THAT RODS HAD MOVED IN UPPER POSITION, RESULTING IN LOSS OF THE CORRECTIVE FORCE. THE SURGEON DECIDED TO CONDUCT RE-OPERATION NEXT WEEK BECAUSE SUCH LOOSENED SET SCREWS MIGHT CONTACT THE HEART OF THE PATIENT. HE WILL USE NON-J&J REPLACEMENTS AT THE RE-OPERATION SCHEDULED NEXT WEEK.

  Patient problems: Failure of Implant; Injury

  MAUDE report 7049012 ↗