EXPEDIUM 179712760Recalls & reported problems
Medos International Sàrl · EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 x 7 x 60mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034067933), received between Oct 24, 2018 and Feb 21, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
- Compatibility Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 21, 2024Compatibility Problem; Compatibility Problem
DEVICE REPORT FROM SWITZERLAND REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 22-JANUARY-2024 DURING AN UNKNOWN PROCEDURE, THE SCREW IN QUESTION WAS FOUND TO BE UNABLE TO CONNECT TO THE SCREWDRIVER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 X 7 X 60MM. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18752861 ↗InjuryOct 24, 2018Break; Break
IT WAS REPORTED THAT THE SCREW WAS IMPLANTED IN THE ILIUM IN THE SURGERY ON (B)(6) 2016. THE HOSPITAL NOTICED THAT THE SCREW HAD BEEN BROKEN IN THE PATIENT¿S BODY BEFORE THE REMOVAL SURGERY ON (B)(6) 2018, WHICH WAS PERFORMED BECAUSE OF INFECTION. WHILE THE SCREW HEAD WAS REMOVED, THE BROKEN SHAFT WAS LEFT IN THE BODY AS PLANNED PREOPERATIVELY. THERE WAS NO SURGICAL DELAY. IT IS POSSIBLE THAT THE SHAFT COME OUT FROM THE ILIUM IN THE FUTURE. THE PATIENT IS FEMALE WHO HAS PARKINSON¿S DISEASE.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 8000194 ↗
Other APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY devices
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- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
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- Elegance® Anterior Cervical Plate 53430114Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430240Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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