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EXPEDIUM 279702070Recalls & reported problems

Medos International Sàrl · EXPEDIUM SPINE SYSTEM COMPRESSOR, PARALLEL ACTION · Class 1

All models of EXPEDIUM (291)

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

Adverse event reports
9
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705034198460), received between Sep 1, 2017 and Feb 4, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (5 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: 1 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 1 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 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

  • Break5
  • Component Missing1
  • Device Slipped1
  • Device-Device Incompatibility1
  • Illegible Information1
  • Mechanical Jam1

Patient problems

  • No Clinical Signs, Symptoms or Conditions6
  • Insufficient Information1
  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 4, 2025Break; Break

    IT WAS REPORTED THAT ON (B)(6) 2025, DURING INSTRUMENTS INSPECTION BEFORE SURGERY, THE XPDM COMPRESSOR WAS FOUND TO BE MALFUNCTIONING. A SCREW OF THE XPDM COMPRESSOR CAME OFF DURING OPERATION CHECK. SINCE THE EVENTS OCCURRED BEFORE SURGERY, ANOTHER INSTRUMENT WITH THE SAME PRODUCT CODE WAS ARRANGED. NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21307846 ↗
  • MalfunctionAug 7, 2024Mechanical Jam; Mechanical Jam

    IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE IN 2024, THE ITEM WAS STICKING DURING COMPRESSION. FRAGMENTS WERE GENERATED AND WERE EASILY REMOVED WITHOUT REQUIRING ADDITIONAL INTERVENTION. THERE WAS NO SURGICAL DELAY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM COMPRESSOR, PARALLEL ACTION. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: Insufficient Information

    MAUDE report 19931560 ↗
  • MalfunctionApr 24, 2024Break; Break

    IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE COMPRESSOR AND DISTRACTOR BROKE DURING CASE. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) XPDM COMPRESSOR, PARALLEL THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19175599 ↗
  • MalfunctionNov 28, 2023Break; Illegible Information; Break; Illegible Information

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN DENMARK AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, THE TIP OF THE INSTRUMENT WAS BROKEN DURING COMPRESSION. THERE WAS NO PATIENT CONSEQUENCE. THE SURGERY WAS PERFORMED AS PLANNED WITH ANOTHER INSTRUMENT. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM COMPRESSOR, PARALLEL ACTION. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18216556 ↗
  • MalfunctionOct 5, 2023Break; Break

    IT WAS REPORTED THAT ON SEPTEMBER 16, 2023, THE FACILITY NOTIFIED OF INSTRUMENTS THAT HAD BEEN BROKEN OR DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. ISSUES WERE DISCOVERED POSTOPERATIVELY. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM COMPRESSOR, PARALLEL ACTION. THIS IS REPORT 3 OF 9 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17875181 ↗
  • MalfunctionAug 7, 2023Device-Device Incompatibility; Device-Device Incompatibility

    DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY FOR AIS (TYPE2) PERFORMED ON (B)(6) 2023. AFTER SETTING RODS, THE SURGEON USED THE COMPRESSOR FOR LEVELING THE VERTEBRAL BODY, BUT THE COMPRESSOR WAS DIFFICULT TO APPLY FORCE THEREFORE COMPETITOR¿S COMPRESSOR WHICH THE SURGEON HAS BEEN FAMILIAR TO USE FOR SETTING THE VERSE SYSTEM AND ALTALYNE RODS WAS USED. A PHENOMENON OCCURRED IN WHICH THE VERSE SYSTEM AND ALTALYNE RODS MOVED EVEN THOUGH THE SURGEON APPLIED A STRONG COMPRESSION AND THE ASSISTANT SURGEON MADE THE FINAL TIGHTENING. THEREFORE, THE SURGEON BECOME ENRAGED THAT THE VERSE SYSTEM MIGHT BE SYSTEMICALLY PROBLEMATIC IN CASES SUCH AS SCOLIOSIS, WHICH REQUIRES STRONG CORRECTION. A COMPETITOR'S DEVICE WAS USED IN THE DISTRACTION PROCEDURE TOO AND THE FINAL TIGHTENING WAS DONE, BUT THE VERSE SYSTEM COULD NOT HOLD THE TIGHTENED POSITION AFTER THE FINAL TIGHTENING. THE SURGEON POINTED OUT THE SHORTCOMINGS OF THE VERSE SYSTEM. TO PREVENT THE IMPLANTS FROM MOVING FROM THE POSITION SET BY THE FINAL TIGHTENING, THE SURGEON DISTRIBUTED THE STRESS SO THAT IT WAS NOT CONCENTRATED IN ONE PLACE AND MANAGED TO COMPLETE TH

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17476604 ↗
  • MalfunctionOct 3, 2022Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN INTERBODY FUSION PROCEDURE FOR SPINAL STENOSIS, THE COMPRESSOR IN QUESTION WAS BROKEN DURING COMPRESSING. THERE WERE NO PROBLEMS THAT INTERRUPTED THE OPERATION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM COMPRESSOR, PARALLEL ACTION. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15527133 ↗
  • MalfunctionAug 26, 2020Device Slipped; Device Slipped

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING THE COMPRESSION OF A SPINE SEGMENT ON (B)(6) 2020, THE LOCKING SCREWS ON THE EXPEDIUM COMPRESSION FORCEPS LOOSENED WHICH RESULTED IN THE INSTRUMENT BECOMING UNUSABLE. THE COMPRESSION COULD BE CARRIED OUT BY USING AN ALTERNATIVE COMPRESSION FORCEPS. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR AN EXPEDIUM COMPRESSOR, PARALLEL. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10453361 ↗
  • MalfunctionSep 1, 2017Component Missing; Component Missing

    COMPRESSOR BROKE, SCREWS FELL APART AND WENT MISSING.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6839725 ↗

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