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EXPEDIUM 179799745Recalls & reported problems

Medos International Sàrl · EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 7 x 45mm · Class 2

All models of EXPEDIUM (291)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034083827), received between Sep 27, 2018 and Sep 27, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Break2

Patient problems

  • Spinal Column Injury2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjurySep 27, 2018Break; Break

    THE FOLLOWING WAS REPORTED: PRODUCT CODE: 179799745. LOT/BATCH/EXP: ATMC7K AND ARKBLR. DID THE EVENT HAPPEN DURING A PROCEDURE? NO. WERE YOU IN THE PROCEDURE AT THE TIME OF THE EVENT? YES. WAS THE PRODUCT BEING USED IN A CLINICAL TRIAL? NO. EVENT OUTCOME/HOW WAS IT MANAGED? THE SCREWS WERE SUCCESSFULLY REMOVED AND REVISED. WAS THERE A PATIENT IMPACT OR WAS THE PROCEDURE EXTENDED GREATER THAN 30 MINUTES DUE TO THE FAILURE? NO. HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? NO. IS THE PRODUCT AVAILABLE FOR RETURN? IF THE ITEM IS RETURNED FROM CSSD FOLLOWING DECOM PLEASE GIVE A DETAILED EXPLANATION OF THE EVENT: THESE SCREWS WERE IMPLANTED AT S1 IN A CONSTRUCT SPANNING L3-S1 WITH CONCORDE CAGES AT L3/4, L4/5 AND L5/S1. BOTH S1 SCREWS BROKE DUE TO THE BREAKAGE AND THE PSEUDOARTHROSIS AT L5/S1 A REVISION SURGERY WAS REQUIRED. THE SCREWS WERE SUCCESSFULLY EXTRACTED (ALL FRAGMENTS) AND REPLACED WITH EXPREDIUM VERSE SCREWS AND THE FUSION EXTENDED TO THE PELVIS. THE CAGE AT L5/S1 WAS ALSO REVISED.

    Patient problems: Spinal Column Injury

    MAUDE report 7914463 ↗
  • InjurySep 27, 2018Break; Break

    THE FOLLOWING WAS REPORTED: PRODUCT CODE : 179799745. LOT/BATCH/EXP: ATMC7K AND ARKBLR . DID THE EVENT HAPPEN DURING A PROCEDURE? NO. WERE YOU IN THE PROCEDURE AT THE TIME OF THE EVENT? YES. WAS THE PRODUCT BEING USED IN A CLINICAL TRIAL? NO. EVENT OUTCOME/HOW WAS IT MANAGED? THE SCREWS WERE SUCCESSFULLY REMOVED AND REVISED. WAS THERE A PATIENT IMPACT OR WAS THE PROCEDURE EXTENDED GREATER THAN 30 MINUTES DUE TO THE FAILURE? NO. HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? NO. IS THE PRODUCT AVAILABLE FOR RETURN? IF THE ITEM IS RETURNED FROM CSSD FOLLOWING DECOM PLEASE GIVE A DETAILED EXPLANATION OF THE EVENT: THESE SCREWS WERE IMPLANTED AT S1 IN A CONSTRUCT SPANNING L3-S1 WITH CONCORDE CAGES AT L3/4, L4/5 AND L5/S1. BOTH S1 SCREWS BROKE DUE TO THE BREAKAGE AND THE PSEUDOARTHROSIS AT L5/S1 A REVISION SURGERY WAS REQUIRED. THE SCREWS WERE SUCCESSFULLY EXTRACTED (ALL FRAGMENTS) AND REPLACED WITH EXPREDIUM VERSE SCREWS AND THE FUSION EXTENDED TO THE PELVIS. THE CAGE AT L5/S1 WAS ALSO REVISED.

    Patient problems: Spinal Column Injury

    MAUDE report 7914269 ↗

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Sources and updates

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