Trios Spinal Surgery Top 7943Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842430103971), received between Oct 5, 2022 and Oct 5, 2022 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITERATURE CITATION: KIM, JI HYUN MDA,*; KIM, SORA MDA; YU, TAEYOUNG MDA; YANG, WOO SEOK MDA; HONG, SEONG WOOK MDA. SUDDEN ARRHYTHMIA IN THE PRONE POSITION DURING SPINAL SURGERY: A CASE REPORT. MEDICINE: AUGUST 19, 2022 - VOLUME 101 - ISSUE 33 - P E30137 DOI: 10.1097/MD.0000000000030137. A 155 CM, 59 KG, 70-YEAR-OLD WOMAN WITH SPINAL STENOSIS WAS UNDERGOING TRANSFORAMINAL LUMBAR INTERBODY FUSION USING THE JACKSON SPINE TABLE (MIZUHO OSI). A SUDDEN CARDIAC ARRHYTHMIA OCCURRED APPROXIMATELY 30 MINUTES AFTER MOVING TO THE PRONE POSITION AND CONTINUED FOR 10 TO 30 SECONDS FOLLOWING SPONTANEOUS RESTORATION TO NORMAL SINUS RHYHM FOR A FEW MINUTES AFTER POSITIONAL CHANGE TO THE SUPINE POSITION. HENCE, INCREASED INTRATHORACIC PRESSURE CAUSED BY THE PRONE POSITION WAS HIGHLY SUSPECTED TO BE THE CAUSE OF THIS EVENT. IT WAS DIFFICULT TO EXACTLY DEFINE THE TYPE OR CAUSE OF THE SUDDEN ARRHYTHMIA AND CONSIDERING THAT OTHER VITAL SIGNS REMAINED STABLE, A CLOSE OBSERVATION WAS KEPT DURING THE LENGTH OF THE OPERATION RATHER THAN APPLYING UNCERTAIN ANTIARRYTHMIC MEDICATION. ALTHOUGH THE JACKSON SPINE TABLE (MIZUHO OSI) IS KNOWN TO HAVE THE LEAST EFFECT ON CARDIAC FUNCTION, ARRHYTHMIA WAS OBSERVED IN

  Patient problems: Arrhythmia

  MAUDE report 15547696 ↗