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
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.