EXPEDIUM 179702535Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034064697), received between Jan 10, 2018 and Jan 10, 2018 — classified as 3 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 10, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED VIA MEDWATCH (B)(4), A YOUNG GIRL WITH SEVERE ADOLESCENT IDIOPATHIC SCOLIOSIS PRESENTED FOR ELECTIVE POSTERIOR SPINAL FUSION AND BONE GRAFTING OF T4-L4 VERTEBRAE, AS WELL AS, EPIDURAL CATHETER PLACEMENT TAT T6 AND T12. THE PATIENT WAS TRANSPORTED TO THE OR AT 0739. MOTOR POTENTIALS WERE UNABLE TO BE OBTAINED FROM THE START OF THE SURGERY. TWO DIMENSIONAL C-ARM XRAYS WERE COMPLETED INTRA-OP. NO CONCERNS WERE NOTED. THE SURGERY WAS COMPLETED AT 1457 WITHOUT ANY CHALLENGES. A "WAKE UP" TEST WAS PERFORMED PER RECOMMENDED GUIDELINES TO ASSESS SENSORIMOTOR FUNCTIONING IN THE ABSENCE OF INTRA-OP MONITORING. UPON AWAKING, THE PATIENT WAS UNABLE TO MOVE HER FEET. SHE WAS EXTUBATED AND BROUGHT TO THE POST ANESTHESIA UNIT FOR FULL WAKE-UP. SHE HAD SENSATION OF HER LEGS BUT WAS UNABLE TO MOVE THEM. SHE HAD AN EMERGENT CT SCAN THAT SHOWED 3 PEDICLE SCREWS IN THE SPINAL CANAL. SHE WAS BROUGHT BACK TO THE OR TO HAVE THE SCREWS REMOVED. SHE CONTINUED TO HAVE INCOMPLETE PARAPLEGIA AFTER SURGERY INCLUDING A LOSS OF BOWEL AND BLADDER CONTROL. SHE WAS TREATED WITH DECADRON AND KETOROLAC. SHE REGAINED SOME MOVEMENT IN HER LEFT LOWER EXTREMITY AND WAS REPORTING BLADDER FULLNESS AND THE S

  Patient problems: Neurological Deficit/Dysfunction; Paralysis

  MAUDE report 7179868 ↗
• InjuryJan 10, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED VIA MEDWATCH (B)(4), A YOUNG GIRL WITH SEVERE ADOLESCENT IDIOPATHIC SCOLIOSIS PRESENTED FOR ELECTIVE POSTERIOR SPINAL FUSION AND BONE GRAFTING OF T4-L4 VERTEBRAE, AS WELL AS, EPIDURAL CATHETER PLACEMENT TAT T6 AND T12. THE PATIENT WAS TRANSPORTED TO THE OR AT 0739. MOTOR POTENTIALS WERE UNABLE TO BE OBTAINED FROM THE START OF THE SURGERY. TWO DIMENSIONAL C-ARM XRAYS WERE COMPLETED INTRA-OP. NO CONCERNS WERE NOTED. THE SURGERY WAS COMPLETED AT 1457 WITHOUT ANY CHALLENGES. A "WAKE UP" TEST WAS PERFORMED PER RECOMMENDED GUIDELINES TO ASSESS SENSORIMOTOR FUNCTIONING IN THE ABSENCE OF INTRA-OP MONITORING. UPON AWAKING, THE PATIENT WAS UNABLE TO MOVE HER FEET. SHE WAS EXTUBATED AND BROUGHT TO THE POST ANESTHESIA UNIT FOR FULL WAKE-UP. SHE HAD SENSATION OF HER LEGS BUT WAS UNABLE TO MOVE THEM. SHE HAD AN EMERGENT CT SCAN THAT SHOWED 3 PEDICLE SCREWS IN THE SPINAL CANAL. SHE WAS BROUGHT BACK TO THE OR TO HAVE THE SCREWS REMOVED. SHE CONTINUED TO HAVE INCOMPLETE PARAPLEGIA AFTER SURGERY INCLUDING A LOSS OF BOWEL AND BLADDER CONTROL. SHE WAS TREATED WITH DECADRON AND KETOROLAC. SHE REGAINED SOME MOVEMENT IN HER LEFT LOWER EXTREMITY AND WAS REPORTING BLADDER FULLNESS AND THE S

  Patient problems: Neurological Deficit/Dysfunction; Paralysis

  MAUDE report 7179819 ↗
• InjuryJan 10, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED VIA MEDWATCH (B)(4), A YOUNG GIRL WITH SEVERE ADOLESCENT IDIOPATHIC SCOLIOSIS PRESENTED FOR ELECTIVE POSTERIOR SPINAL FUSION AND BONE GRAFTING OF T4-L4 VERTEBRAE, AS WELL AS, EPIDURAL CATHETER PLACEMENT TAT T6 AND T12. THE PATIENT WAS TRANSPORTED TO THE OR AT 0739. MOTOR POTENTIALS WERE UNABLE TO BE OBTAINED FROM THE START OF THE SURGERY. TWO DIMENSIONAL C-ARM XRAYS WERE COMPLETED INTRA-OP. NO CONCERNS WERE NOTED. THE SURGERY WAS COMPLETED AT 1457 WITHOUT ANY CHALLENGES. A "WAKE UP" TEST WAS PERFORMED PER RECOMMENDED GUIDELINES TO ASSESS SENSORIMOTOR FUNCTIONING IN THE ABSENCE OF INTRA-OP MONITORING. UPON AWAKING, THE PATIENT WAS UNABLE TO MOVE HER FEET. SHE WAS EXTUBATED AND BROUGHT TO THE POST ANESTHESIA UNIT FOR FULL WAKE-UP. SHE HAD SENSATION OF HER LEGS BUT WAS UNABLE TO MOVE THEM. SHE HAD AN EMERGENT CT SCAN THAT SHOWED 3 PEDICLE SCREWS IN THE SPINAL CANAL. SHE WAS BROUGHT BACK TO THE OR TO HAVE THE SCREWS REMOVED. SHE CONTINUED TO HAVE INCOMPLETE PARAPLEGIA AFTER SURGERY INCLUDING A LOSS OF BOWEL AND BLADDER CONTROL. SHE WAS TREATED WITH DECADRON AND KETOROLAC. SHE REGAINED SOME MOVEMENT IN HER LEFT LOWER EXTREMITY AND WAS REPORTING BLADDER FULLNESS AND THE S

  Patient problems: Neurological Deficit/Dysfunction; Paralysis

  MAUDE report 7179728 ↗