ENCORE AUTOMATIC EXAM CHAIR
Received Jan 26, 2022 · Event occurred Jan 4, 2022
Report MW5107016 · MDR key 13367155
Device
Product problems
- Patient-Device Incompatibility
- Unintended Movement
Patient
62 YR · Male
- Fall
- Paralysis
- Numbness
- Spinal Cord Injury
- Vertebral Fracture
- Fall
- Paralysis
- Numbness
- Spinal Cord Injury
- Vertebral Fracture
Narrative
Description of Event or Problem
ON (B)(6) 2022, PATIENT LOST HIS SENSATION AND INABILITY TO MOVE ALL EXTREMITIES AFTER FALLING BACKWARD WHILE SITTING ON A CHAIR DURING AN EYE APPOINTMENT. PROVIDER NEEDED TO DO A PERIPHERAL RETINAL EXAM AND AS THE BACK OF THE CHAIR WAS GOING BACK, IN A SLOW, MOTORIZED FASHION, THE CHAIR SUDDENLY TIPPED BACKWARDS. PATIENT WAS SENT TO ED AND CT FULL SPINE SHOWED C5-C6 FRACTURE. ON THE SAME DAY, PATIENT HAD C2-T2 POSTERIOR SPINAL INSTRUMENTED FUSION (PSIF) AND C5-C6 LAMINECTOMY. PATIENT IS STILL IN THE HOSPITAL. THE CHAIR SITS ON A CHAIR MOVER WITH UNKNOWN MANUFACTURER, BRAND, AND SERIAL NUMBER. "TRAUMATIC GRADE 2 ANTEROLISTHESIS OF C5 ON C6 (9/38) WITH FRACTURE THROUGH THE OSSIFIED ANTERIOR LONGITUDINAL LIGAMENT, POSTERIOR LONGITUDINAL LIGAMENT, AND INTERVERTEBRAL DISC. THE OSSEOUS SPINAL CANAL IS SEVERELY NARROWED AT THIS LEVEL WITH PRESUMED HIGH-GRADE SPINAL CORD INJURY AND/OR TRANSECTION. THE LEFT C5-C6 FACET JOINT IS JUMPED. THE RIGHT C5-C6 FACET JOINT IS PERCHED WITH PROBABLE ACUTE MINIMALLY DISPLACED FRACTURE OF THE RIGHT C6 SUPERIOR ARTICULAR PILLAR. THIS IS A RED DOT POLICY INJURY." FDA SAFETY REPORT ID# (B)(4).