MaXcess 3240309Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887517196699), received between Jul 20, 2023 and Jun 30, 2026 — classified as 1 death, 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON WAS DOING A REVISION SURGERY WHERE THE ORIGINAL SURGERY WAS COMPLETED IN 2014 USING ANOTHER COMPANY'S PRODUCTS (MEDACTA) THE SURGEON DID AN XLIF USING THE NUVASIVE MAXCESS 4 RETRACTOR AND INSERTER MODULUS CAGES WITH SINGLE HOLE PLATES ATTACHED AT THOSE TWO LEVELS. HE THEN PROCEEDED TO MOVE THE RETRACTOR UP TO L1/2 AND, WHILST POSITIONING THE RETRACTOR, HE MADE A COMMENT ABOUT THE PATIENT "HOSING BLOOD". HE PACKED THE WOUND USING VARIOUS HEMOSTATIC AGENTS AND GAUZE ON AND OFF FOR APPROXIMATELY 30 MINUTES BEFORE ASKING IF A VASCULAR SURGEON COULD BE CONTACTED AS THE PATIENT CONTINUED TO BLEED. AT THIS POINT DR. ROSENBERG TOLD ME THAT HE WAS GOING TO ABORT ANY INSTRUMENTATION AT L1/2. THE ANESTHETIST APPROXIMATED THAT THE BLOOD LOSS WAS 100-200ML. THE VASCULAR SURGEON SCRUBBED IN AND AFTER APPROXIMATELY AN HOUR OF TRYING TO IDENTIFY AND STOP THE BLEEDING HE DECIDED THAT PATIENT NEEDED TO BE MOVED TO A SUPINE POSITION SO THAT HE COULD GET BETTER VISUALISATION. WHILE IN THIS POSITION THE VASCULAR SURGEON IDENTIFIED THAT THERE WAS A KIDNEY INVOLVED AND THAT THERE WAS GAUZE IN/AROUND ONE OF THE PATIENT'S KIDNEY'S. HE ASKED FOR A GENERAL SURGEON TO BE CALLE

  Patient problems: Kidney injury

  MAUDE report 25669246 ↗
• MalfunctionDec 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE RETRACTOR BODY WILL NOT LOCK IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23804790 ↗
• DeathFeb 26, 2024Malposition of Device; Malposition of Device

  ON (B)(6) 2024 A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE FROM L2 TO L5. WHILE PLACING THE RETRACTOR AT L4/L5 TO PLACE THE VERTEBRAL SPACER THE PATIENT BEGAN TO EXPERIENCE BLEEDING. NO INFORMATION WAS AVAILABLE AS TO WHAT CAUSED THE BLOOD VESSEL DAMAGE. THE SURGEON ATTEMPTED TO STOP THE BLEEDING BY APPLYING PRESSURE WITH GAUZE BUT NO ADDITIONAL INFORMATION WAS AVAILABLE ON WHAT TYPE OF HEMOSTASIS WAS CONDUCTED. IT APPEARS THAT A BLOOD TRANSFUSION WAS GIVEN TO THE PATIENT BUT NO INFORMATION COULD BE PROVIDED ON THE AMOUNT OF BLOOD THAT WAS LOST OR THE AMOUNT GIVEN DURING THE TRANSFUSION. ON FEBRUARY 1, 2024, THE INVOLVED SALES REP RECEIVED INFORMATION FROM ANOTHER SURGEON THAT THE PATIENT HAS PASSED AWAY. NO ADDITIONAL MEDICAL HISTORY COULD BE PROVIDED FOR THE PATIENT RELATING TO CO-MORBIDITIES, MEDICATIONS OR ANYTHING THAT MAY HAVE CONTRIBUTED TO THE BLEEDING. THE PATIENTS CAUSE OF DEATH COULD NOT BE CONFIRMED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18784250 ↗
• InjuryJul 20, 2023Unintended Movement; Unintended Movement

  DURING A SPINAL PROCEDURE THE RETRACTOR WAS LOOSE, SPLAYED IN-SITU AND CAUSED AN INJURY TO THE PATIENT'S MUSCLE AND MINOR BLEEDING. NO TRANSFUSION WAS REQUIRED AND NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Muscle/Tendon Damage

  MAUDE report 17357498 ↗