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EXPEDIUM 299704175Recalls & reported problems

Medos International Sàrl · EXPEDIUM SPINE SYSTEM ROD CLAMP · 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 10705034467313), received between Oct 28, 2019 and Oct 17, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Corroded” (3 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: 0 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: 2 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Corroded3
  • Device-Device Incompatibility2
  • Material Twisted/Bent2
  • Mechanical Jam2

Patient problems

  • No Clinical Signs, Symptoms or Conditions4
  • No Consequences Or Impact To Patient4
  • No Patient Involvement1

Recent adverse event reports

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

  • MalfunctionOct 17, 2024Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED ON AN UNKNOWN DATE, THE INSTRUMENTS ARE WORN OUT FROM USE AND CORRECTIONAL MANEUVERS ARE NEEDED BY SURGEONS PERFORMING CASES. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20470203 ↗
  • MalfunctionOct 17, 2024Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED ON AN UNKNOWN DATE, THE INSTRUMENTS ARE WORN OUT FROM USE AND CORRECTIONAL MANEUVERS ARE NEEDED BY SURGEONS PERFORMING CASES. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20470105 ↗
  • MalfunctionJun 17, 2022Device-Device Incompatibility; Device-Device Incompatibility

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT DURING AN INCOMING INSPECTION AT THE LOANER SET DEPARTMENT OF SET RETURNING FROM THE CUSTOMER, IT WAS NOTICED THAT THE BAR HOLDING TONGS DID NOT ENGAGE AND CANNOT BE OPENED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE ROD CLAMP THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14735084 ↗
  • MalfunctionJun 17, 2022Device-Device Incompatibility; Device-Device Incompatibility

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT DURING AN INCOMING INSPECTION AT THE LOANER SET DEPARTMENT OF SET RETURNING FROM THE CUSTOMER, IT WAS NOTICED THAT THE BAR HOLDING TONGS DID NOT ENGAGE AND CANNOT BE OPENED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) ROD CLAMP. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14735069 ↗
  • MalfunctionNov 27, 2019Corroded; Corroded

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE EXPEDIUM INSTRUMENTS ARE SHOWING PITTING CORROSION. THIS WAS NOTICED IN CENTRAL STERILE SERVICE DEPARTMENT (CSSD). THERE WAS NO PATIENT INVOLVEMENT REPORTED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Patient Involvement

    MAUDE report 9384475 ↗
  • MalfunctionOct 30, 2019Mechanical Jam; Mechanical Jam

    ROD CLAMP´S ADVANTAGEOUS ONE-HANDED LOCKING AND UNLOCKING MECHANISM IS JAMMING TEMPORARILY. NO SURGICAL DELAY, NO ADVERSE PATIENT CONSEQUENCES. ANOTHER INSTRUMENT WAS AVAILABLE AND USED WITHOUT ISSUES. THIS COMPLAINT INVOLVES TWO (2) DEVICE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9255600 ↗
  • MalfunctionOct 30, 2019Mechanical Jam; Mechanical Jam

    ROD CLAMP´S ADVANTAGEOUS ONE-HANDED LOCKING AND UNLOCKING MECHANISM IS JAMMING TEMPORARILY. NO SURGICAL DELAY, NO ADVERSE PATIENT CONSEQUENCES. ANOTHER INSTRUMENT WAS AVAILABLE AND USED WITHOUT ISSUES. THIS COMPLAINT INVOLVES TWO (2) DEVICE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9255545 ↗
  • MalfunctionOct 28, 2019Corroded; Corroded

    CUSTOMER HAVE FOUND RUST ON INSTRUMENT, ART 299704175, ROD CLAMP. 2PCS. BEFORE SURGERY, NO PATIENT WAS INVOLVED. NO EXTRA ACTIONS NEEDED. THIS COMPLAINT INVOLVES TWO (2) DEVICE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9243785 ↗
  • MalfunctionOct 28, 2019Corroded; Corroded

    CUSTOMER HAVE FOUND RUST ON INSTRUMENT, ART 299704175, ROD CLAMP. 2PCS. BEFORE SURGERY, NO PATIENT WAS INVOLVED. NO EXTRA ACTIONS NEEDED. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9243771 ↗

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