EXPEDIUM 179702640Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034064871), received between Nov 21, 2017 and Oct 18, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING THE CLOSURE OF THE SYSTEM AT THE TIME OF THE REDUCTION OF THE BAR AND TORQUING, THE THREAD PITCHES OF THE NUTS WERE FOUND TO BE DAMAGED ALONG WITH THE INTERNAL THREAD OF THE MONO-AXIAL SCREWS. TABLE TESTS OF THE CLOSING PROCESS WERE PERFORMED WITHOUT RESISTANCE OF THE BAR AND THE SAME DIFFICULTY PRESENTED. POLY-AXIAL SCREWS WERE PASSED, AND SYSTEM SHUTDOWN WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM MONOAXIAL SCREW 5.5 X 6 X 40MM. THIS IS REPORT 2 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17956367 ↗
• 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 7048966 ↗