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EXPEDIUM 299704190Recalls & reported problems

Medos International Sàrl · EXPEDIUM SPINE SYSTEM CORONAL IN-SITU BENDER, RIGHT 5.5 · Class 1

Adverse event reports
9
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705034466903), received between Nov 27, 2023 and Apr 20, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (5 reports).

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.

Reports received per month

Nov 2023: 1 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 2 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 4 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520264
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Material Deformation5
  • Break4
  • Corroded1

Patient problems

  • No Clinical Signs, Symptoms or Conditions9

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 20, 2026Material Deformation

    IT WAS REPORTED THAT BENDER WAS DAMAGED, METAL BENT. THERE WAS NO PATIENT CONSEQUENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24928020 ↗
  • MalfunctionApr 20, 2026Material Deformation

    IT WAS REPORTED THAT BENDER WAS DAMAGED, METAL BENT. THERE WAS NO PATIENT CONSEQUENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24928013 ↗
  • MalfunctionApr 20, 2026Material Deformation

    IT WAS REPORTED THAT BENDER WAS DAMAGED, METAL BENT. THERE WAS NO PATIENT CONSEQUENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24927995 ↗
  • MalfunctionApr 20, 2026Material Deformation

    IT WAS REPORTED THAT POLY SHAFT DRIVERS ARE STRIPPED. THE HANDLES ARE NOT RATCHING. THE TAPS ARE DULL AND THE BENDERS ARE DAMAGED, METAL BENT. ROD HOLDERS WORN. NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24925266 ↗
  • MalfunctionMar 20, 2026Break

    IT WAS REPORTED THAT THE EXPEDIUM VERSE CORONAL BENDER SNAPPED AT THE DISTAL END WHILST BENDING A 5.5 COCR ROD. THERE WAS NO PATIENT IMPACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24649146 ↗
  • MalfunctionNov 11, 2025Material Deformation; Material Deformation

    IT WAS REPORTED THAT PRODUCTS ARE BENT DUE TO USE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23523917 ↗
  • MalfunctionApr 23, 2025Break; Break

    IT WAS REPORTED THAT THE FRENCH BENDER CENTER PORTION BROKEN. CORONAL BENDERS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21892967 ↗
  • MalfunctionApr 23, 2025Break; Break

    IT WAS REPORTED THAT THE FRENCH BENDER CENTER PORTION BROKEN. CORONAL BENDERS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21892233 ↗
  • MalfunctionNov 27, 2023Break; Corroded; Break; Corroded

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN DENMARK AS FOLLOWS: IT WAS REPORTED THAT AFTER SURGERY, THE STERILE DEPARTMENT FOUND SIGNS OF SMALL ¿HOLES¿ AND RUST ON THE SURFACE OF THE INSTRUMENTS. THE INSTRUMENTS ARE RARELY USED. IT LOOKS LIKE A ¿NON-MECHANICAL¿ REASON OF THE SURFACE CHANGES. INSTRUMENTS AND DECONTAMINATION CERTIFICATION WILL BE PICKED UP NEXT WEEK AT CLINIC. SAME LIKE PRODUCT WAS USED TO MANAGE THE PROBLEM. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CORONAL IN-SITU BENDER, RIGHT THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18212174 ↗

Other BENDER devices

All BENDER devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.