inforMED
InjuryGXZ

SUBDERNAL NEEDLE ELECTRODE

Received Dec 19, 2025

Report 1067162-2025-00008 · MDR key 23854224

Device

Generic name

Subdernal Needle Electrode

Model number

UNKNOWN

Catalog number

UNKNOWN

Lot number

UNKNOWN

Product problems

  • Detachment of Device or Device Component
  • Detachment of Device or Device Component

Patient

NA · Unknown

  • Foreign Body In Patient
  • Foreign Body In Patient

Narrative

Description of Event or Problem

THE DATE OF THE EVENT AND THE PART AND LOT NUMBERS ARE UNKNOWN. DURING A 9.5-HOUR T2-PELVIS POSTERIOR SPINAL FUSION, PAIRED 22 MM SUBDERMAL NEEDLES WERE USED IN ALL FOUR LIMBS AND THE NECK, WITH SPACING OF APPROXIMATELY 1-2 INCHES IN THE LIMBS AND ABOUT 5 INCHES IN THE NECK. ALL NEEDLES WERE INSERTED UP TO THE BLACK HUB, AND THE NEEDLE OF INTEREST WAS PLACED AT THE RIGHT POSTERIOR KNEE TO MONITOR THE RIGHT PERONEAL NERVE. AT BREAKDOWN, IT WAS OBSERVED THAT THE NEEDLE ASSOCIATED WITH THE GREEN LEAD HAD BROKEN OFF FROM THE BLACK HUB. THE DETACHED NEEDLE WAS IDENTIFIED WHEN THE DRAPES WERE REMOVED AND THE IOM TECHNOLOGIST ATTEMPTED TO REMOVE IT. DURING BREAKDOWN, THE PATIENT WAS NOTED TO BE SWEATY, AND THE RIGHT LEG HAD FALLEN OFF THE SURGICAL TABLE. DESPITE THESE OBSERVATIONS, NO SIGNIFICANT NEUROMONITORING CHANGES WERE NOTED DURING THE PROCEDURE..