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EXPEDIUM 279729930Recalls & reported problems

Medos International Sàrl · EXPEDIUM SPINE SYSTEM TABLE TOP ROD CUTTER · Class 1

All models of EXPEDIUM (291)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
7
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705034200125), received between Aug 12, 2020 and Jun 17, 2025 — classified as 7 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 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 1 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break6
  • Detachment of Device or Device Component1
  • Material Deformation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions6
  • No Patient Involvement1

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 17, 2025Break; Break

    IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2025. BEFORE SURGERY, WHEN THE ROD CUTTER WAS CLEANED, THE SCREW CAME OFF. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT WAS STABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22235278 ↗
  • MalfunctionMay 2, 2025Break; Break

    IT WAS REPORTED THAT PARTS OF THE PRODUCT CAME OFF AFTER PRE-OPERATIVE CLEANING ON AN UNKNOWN DATE. IT WAS CONFIRMED THAT THE REAR PART OF THE ROD CUTTER CAME OFF. NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21952097 ↗
  • MalfunctionMar 12, 2025Break; Break

    IT WAS REPORTED THE INSTRUMENT IS BROKEN. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 5 MINUTE SURGICAL DELAY. PATIENT IS DOING WELL. NO PATIENT CONSEQUENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21582209 ↗
  • MalfunctionDec 28, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

    IT WAS REPORTED THAT ON DECEMBER 6, 2023, THE ROD CUTTER FELL APART AND ALMOST DROPPED IN SOMEONE¿S FOOT. THE DEVICE WAS IN THREE PIECES. THERE WAS NO PATIENT INVOLVEMENT; THE EVENT OCCURRED POSTOPERATIVELY. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM TABLE TOP ROD CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18408663 ↗
  • MalfunctionMay 23, 2023Break; Break

    IT WAS REPORTED THAT ON (B)(6) 2023, THAT THE FRONT END OF TABLE TOP ROD CUTTER SHEARED OFF WHILE CUTTING A 5.5 COBALT CHROME ROD INTRA-OP. NO HARM TO PATIENT. SLIGHT DELAY OF SURGERY WHILE ANOTHER ROD CUTER WAS OPENED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH 2 MINUTES OF SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) IEXP ROD CUTTER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16983602 ↗
  • MalfunctionDec 14, 2021Material Deformation; Material Deformation

    IT WAS ALSO REPORTED THAT THE SURGEON USED THE ROD CUTTER WITH STRONG PRESSURE AND WAS ABLE TO CUT IT STRAIGHT. PATIENT OUTCOME IS REPORTED AS STABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13005871 ↗
  • MalfunctionAug 12, 2020Break; Break

    IT WAS REPORTED THAT ON (B)(6) 2020, THE EXPEDIUM ROD CUTTER BROKE IN CONJUNCTION WITH A PROTOTYPE MATERIAL DURING BENCHTOP CUTTING OF NEW ROD MATERIALS (MP35N). THE ROD CUTTER FRACTURED ABOVE THE 5.5MM DIAMETER CUTTING HOLE. THERE IS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) IEXP ROD CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Patient Involvement

    MAUDE report 10396233 ↗

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Sources and updates

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