EXPEDIUM 279712850Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034199108), received between Apr 24, 2019 and May 9, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2022 DURING SPINAL FUSION, WHILE A T12-S2AI INSTRUMENTED FUSION, DOCTOR FORCE ON CORONAL BENDERS AND BENT THE INSTRUMENT ITSELF. THE BENDERS WERE REMOVED FROM THE FIELD AND THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS REPORT IS FOR BENDER-RIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14336740 ↗
• InjuryApr 24, 2019Material Twisted/Bent; Material Twisted/Bent

  THE FOLLOWING WAS REPORTED: MEDICAL STORY: ON (B)(6) 2019, SURGERY IS PERFORMED TO CORRECT SCOLIOSIS OF THE PATIENT'S INITIAL FC. THE INSTRUMENTS TO BE USED PROVIDED BY PATIENT'S MEDICAL COVERAGE AND EXPIDIURN DEPUY SPINE FROM THE JOHNSON AND JOHNSON COMPANY. BEFORE STARTING THE SURGICAL PROCEDURE, WE PROCEED TO THE USUAL CONTROL OF THE MATERIAL PROVIDED BY THE (B)(4) (DISTRIBUTOR). SUCH CONTROL IS DID BY THE COMPANY INSTRUMENTALIST (B)(4) WHO TELLS US THAT ALL THE MATERIAL IS FIT AND THERE IS SUFFICIENT NUMBER OF IMPLANTS OF ALL SIZES. AFTER THE CONFIRMATION OF THE INSTRUMENTALIST THE PATIENT IS ASKED TO TURN TO THE OPERATING ROOM. WHEN TRYING TO START WITH THE CORRECTIVE MANEUVERS AND FINAL ADJUSTMENT OF THE SYSTEM WE FIND OURSELVES WITH THE FOLLOWING DIFFICULTIES FOUND WITH THE COMPANY'S INSTRUMENTATION AND THE ENTIRE SURGICAL TEAM. THE FRONT GRIPS ARE EXTREMELY WORN AND OPEN SO IT IS PRACTICALLY IMPOSSIBLE TO PERFORM THE GRIPPING MANEUVERS. (VIDEO OF THE MANEUVER IS MADE). THE CUT IN SITU BARS IS IN BAD CONDITION AND IS NOT SUITABLE FOR CUTTING COBALT CHROME BARS BECAUSE I DO NOT KNOW HARD ENOUGH. BENDING OF THE CUTTING EDGE OF THE BARS IS OBSERVED WHICH MAKES IT IMPOSSIBLE TO

  Patient problems: No Code Available

  MAUDE report 8547610 ↗