Thompson 10045334Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00851099006257), received between Apr 2, 2026 and Apr 7, 2026 — classified as 2 injuries.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, (B)(4) (FOR, HCP, REP): INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING PATIENT HAVING L4/5, L5/S OLIF DUE TO ISOLATION. LEVEL IMPLANTED WAS L4/5, L5/S. IT WAS REPORTED THAT THE COMMON ILIAC VEIN WAS DAMAGED AND A LARGE AMOUNT OF HEMORRHAGING OCCURRED WHICH MAY LEAD TO DEATH OR DISABILITY. BLEEDING WAS OBSERVED GRADUALLY AFTER THE L5/S IMPLANT WAS INSERTED AND ATTEMPTED TO STOP THE BLEEDING WITH THE HEMOSTATIC AGENT FLOSEAL AND SURGE FLOW, BUT HEMOSTASIS COULD NOT BE ACHIEVED. WHEN THE WOUND RETRACTOR WAS REMOVED, A LARGE AMOUNT OF HEMORRHAGING WAS OBSERVED AND THE BLEEDING WAS SUPPRESSED WITH GAUZE, BUT HEMOSTASIS COULD NOT BE ACHIEVED, SO A SURGEON FROM CARDIOVASCULAR SURGERY WAS CONTACTED TO COME. THE POSITION WAS CHANGED FROM LATERAL TO SUPINE AND THEN SWITCHED TO THE CARDIOVASCULAR SURGEON, THE BLEEDING SITE IS SPECIFIED AND THEN SUTURED TO STOP THE BLEEDING. BLOOD PRESSURE DROPPED TO 50 MIDWAY, BUT RECOVERED. ACCORDING TO THE CARDIOVASCULAR SURGEON, VEIN WAS PUSHED SLIGHTLY, BUT IT WOULD PROBABLY BE OKAY. THE PATIENT MIGHT EXPERIENCE SWELLING AFTER THE SURGERY, BUT IT WILL RETURN TO NORMAL. ACCORDING TO THE SUR

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24801584 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  ON 2025-07-25 MPXR 1327162 (FOR, HCP, REP): INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING PATIENT HAVING L4/5, L5/S OLIF DUE TO ISOLATION. LEVEL IMPLANTED WAS L4/5, L5/S. IT WAS REPORTED THAT THE COMMON ILIAC VEIN WAS DAMAGED AND A LARGE AMOUNT OF HEMORRHAGING OCCURRED WHICH MAY LEAD TO DEATH OR DISABILITY. BLEEDING WAS OBSERVED GRADUALLY AFTER THE L5/S IMPLANT WAS INSERTED AND ATTEMPTED TO STOP THE BLEEDING WITH THE HEMOSTATIC AGENT FLOSEAL AND SURGE FLOW, BUT HEMOSTASIS COULD NOT BE ACHIEVED. WHEN THE WOUND RETRACTOR WAS REMOVED, A LARGE AMOUNT OF HEMORRHAGING WAS OBSERVED AND THE BLEEDING WAS SUPPRESSED WITH GAUZE, BUT HEMOSTASIS COULD NOT BE ACHIEVED, SO A SURGEON FROM CARDIOVASCULAR SURGERY WAS CONTACTED TO COME. THE POSITION WAS CHANGED FROM LATERAL TO SUPINE AND THEN SWITCHED TO THE CARDIOVASCULAR SURGEON, THE BLEEDING SITE IS SPECIFIED AND THEN SUTURED TO STOP THE BLEEDING. BLOOD PRESSURE DROPPED TO 50 MIDWAY, BUT RECOVERED. ACCORDING TO THE CARDIOVASCULAR SURGEON, VEIN WAS PUSHED SLIGHTLY, BUT IT WOULD PROBABLY BE OKAY. THE PATIENT MIGHT EXPERIENCE SWELLING AFTER THE SURGERY, BUT IT WILL RETURN TO NORMAL. ACCORDING TO THE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24767672 ↗