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EXPEDIUM 179722155Recalls & reported problems

Medos International Sàrl · EXPEDIUM SPINE SYSTEM POLYAXIAL SCREW 5.5 x 10 x 55mm · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034070179), received between Aug 10, 2023 and Aug 10, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Slipped” (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.

Most reported problems

Device problems

  • Device Slipped1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 10, 2023Device Slipped; Device Slipped

    DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT SURGERY ON (B)(6) 2018. IN THE SURGERY, L4 TO S WERE FIXED WITH MATRIX IMPLANTS. POSTOPERATIVELY, ADJACENT SEGMENT DISEASE (ASD) OCCURRED, AND A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023. DURING THE REVISION SURGERY, THE MATRIX SCREW AT LEFT-SIDE S WAS FOUND TO BE LOOSE, AND WAS TO BE REPLACED WITH AN EXPEDIUM SCREW DI10.0×55. DURING INSERTION OF THE EXPEDIUM SCREW, THE TIP OF THE SCREWDRIVER WAS DAMAGED AND CAUGHT INSIDE THE CORE, MAKING IT IMPOSSIBLE TO PROCEED WITH SCREW INSERTION. THE SCREW WAS EXTRACTED AND ANOTHER EXPEDIUM SCREW (DI10.0×45) WAS INSERTED. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHIN THIRTY MINUTES DELAY. PATIENT WAS STABLE. THIS REPORT IS FOR AN EXP DI POLY SCREW 10X55MM TI. THIS IS REPORT 1 OF 1 AND CAPTURES THE INTRAOPERATIVE INCIDENT. THE CAUSE OF THE REVISION SURGERY IS CAPTURED UNDER (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17503483 ↗

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