EXPEDIUM 279702400Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705034198590), received between Jun 29, 2018 and Jun 8, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2026Break

  IT WAS REPORTED THAT A 4.35MM DOUBLE-LEAD TAP BROKE INTRAOPERATIVELY DURING A PEDIATRIC SCOLIOSIS SURGERY. THE TIP OF THE TAP BROKE OFF WHILE PREPARING THE LEFT T4 PEDICLE, BUT THE FRAGMENT WAS EASILY RECOVERED. FOLLOWING THE INCIDENT, THE PATIENT EXPERIENCED LOSS OF MOTOR FUNCTION ON THE RIGHT SIDE, WITH SENSORY SIGNALS RECOVERING BUT NOT THE MOTOR FUNCTION. THE SURGERY WAS DELAYED BY 60-90 MINUTES TO REMOVE AND REINSERT SCREWS FROM T4-6 BILATERALLY, AND A NEUROSURGEON WAS CALLED TO REPAIR A CEREBROSPINAL FLUID (CSF) LEAK. THE PATIENT UNDERWENT AN AWAKE TEST, RODS AND SET SCREWS WERE IMPLANTED, AND THE SURGERY WAS COMPLETED WITHOUT DEFORMITY CORRECTION. MULTIPLE MOTOR TESTS SHOWED NO CHANGE, AND THE PATIENT WAS SENT FOR MRI POST-SURGERY.

  Patient problems: Insufficient Information; Nerve Damage

  MAUDE report 25434899 ↗
• MalfunctionFeb 12, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT IT WAS A THORACIC FIXATION WITH EXPEDIUM 5.5 SYSTEM DUE TO A TUMOR AND THE SURGICAL PLAN WAS FOR TH2 - TH6 FIXATION, BUT SINCE THE 4.35 MM TAP BROKE INTO THE VERTEBRAL BODY DURING THE OPERATION, A TH3 - TH6 FIXATION WAS PERFORMED. THE BROKEN INSTRUMENT WAS LEFT IN THE VERTEBRAL BODY AS THE RISK OF REMOVAL WAS CONSIDERED GREATER THAN LEAVING IT IN PLACE, GIVEN THE PROXIMITY TO THE DURA AND EXITING ROOT AND THE ASSOCIATED RISK OF NEUROLOGICAL DAMAGE. THE PATIENT IS DOING WELL, AS FAR AS HER UNDERLYING DISEASE ALLOWS.

  Patient problems: Foreign Body In Patient

  MAUDE report 24327245 ↗
• MalfunctionSep 8, 2025Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT THE PRODUCT WAS BENT/DAMAGED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22991934 ↗
• MalfunctionSep 8, 2025Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT THE PRODUCT WAS BENT/DAMAGED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22991932 ↗
• MalfunctionOct 17, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT NO OTHER MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20472366 ↗
• MalfunctionDec 16, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT THE SURGEON WAS PERFORMING A L4-S1 POSTERIOR FUSION AND WHEN HE WAS USING THE 4.35MM TAP ON THE 5TH SCREW HOLE, THE TAP SHAFT BROKE JUST ABOVE THE THREADED PORTION. SURGEON WAS ABLE USE A BONE RONGUER TO REMOVE THE BROKEN OFF PORTION. THIS TAP WAS PLACED TO THE SIDE AND AFTER THE CASE IT WAS DECONTAMINATED IN CSSD AND I COLLECTED IT FOR RETURN TO THE OFFICE WHEN I AM THERE NEXT. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. PATIENT STATUS/ OUTCOME / CONSEQUENCES :NO. THIS REPORT IS FOR ONE (1) 4.35MM DOUBLE-LEAD TAP THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15995999 ↗
• MalfunctionJan 16, 2019Break; Break

  IT WAS REPORTED THAT THE POSTERIOR LUMBAR INTERBODY FUSION SURGERY WAS PERFORMED ON (B)(6) 2018 TO FIX L4. DURING THE SURGERY, IT WAS REPORTED THAT THE TIP OF THE TAP WAS BROKEN AT THE 30MM FROM THE TIP. THE BROKEN FRAGMENT WAS REMOVED BY USING PLIER. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8254093 ↗
• MalfunctionJun 29, 2018Break; Break

  EXPEDIUM 4.35 MM TAP BROKE DURING SURGERY, DISTAL END COULD BE REMOVED FROM PATIENT. PATIENT CONSEQUENCE?: NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT?: YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7651920 ↗