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EXPEDIUM 179963600Recalls & reported problems

Medos International Sàrl · EXPEDIUM SPINE SYSTEM ROD, STRAIGHT (WITH HEX ENDS) 6.35 x 600mm · Class 2 · Implant

All models of EXPEDIUM (291)

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

Adverse event reports
6
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034091686), received between Nov 15, 2021 and Nov 15, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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

  • Break6

Patient problems

  • No Clinical Signs, Symptoms or Conditions6

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 15, 2021Break; Break

    IT WAS REPORTED THAT ON (B)(6) 2021, THE RODS WERE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) TI STRAIGHT ROD (HEX END), 600MM. THIS IS REPORT 10 OF 13 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12815397 ↗
  • MalfunctionNov 15, 2021Break; Break

    IT WAS REPORTED THAT ON (B)(6) 2021, THE RODS WERE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT (B)(4). THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) TI STRAIGHT ROD (HEX END), 600MM. THIS IS REPORT 7 OF 13 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12815239 ↗
  • MalfunctionNov 15, 2021Break; Break

    IT WAS REPORTED THAT ON (B)(6) 2021, THE RODS WERE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT (B)(4). THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) TI STRAIGHT ROD (HEX END), 600MM. THIS IS REPORT 5 OF 13 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12815165 ↗
  • MalfunctionNov 15, 2021Break; Break

    IT WAS REPORTED THAT ON (B)(6) 2021, THE RODS WERE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT (B)(4). THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) TI STRAIGHT ROD (HEX END), 600MM. THIS IS REPORT 3 OF 13 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12815127 ↗
  • MalfunctionNov 15, 2021Break; Break

    IT WAS REPORTED THAT ON (B)(6) 2021, THE RODS WERE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT (B)(4). THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) TI STRAIGHT ROD (HEX END), 600MM. THIS IS REPORT 2 OF 13 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12815098 ↗
  • MalfunctionNov 15, 2021Break; Break

    IT WAS REPORTED THAT ON (B)(6) 2021, THE RODS WERE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT (B)(4). THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) TI STRAIGHT ROD (HEX END), 600MM. THIS IS REPORT 1 OF 13 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12815050 ↗

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Sources and updates

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