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EXPEDIUM 279763010Recalls & reported problems

Medos International Sàrl · EXPEDIUM SPINE SYSTEM MODULAR SCREWDRIVER SHAFT 6.35 (T27) · Class 1

All models of EXPEDIUM (291)

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

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034200682), received between Jul 31, 2020 and Apr 4, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (3 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.

Reports received per month

Nov 2023: 0 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: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 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

  • Material Twisted/Bent3

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 4, 2024Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THE TIP OF THE INSTRUMENT WAS WORN DOWN. NO PATIENT OUTCOME REPORTED. THIS REPORT IS FOR ONE T27 MODULAR DRIVER SHAFT FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19039963 ↗
  • MalfunctionJul 6, 2021Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE THE T27 DRIVER STRIPPED SCREW INTERFACE UPON SCREW INSERTION DURING SURGERY. THERE WAS NO SURGICAL DELAY. THERE WERE NO FRAGMENTS GENERATED. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR (1) EXPEDIUM SPINE SYSTEM MODULAR SCREWDRIVER SHAFT 6.35 (T27). THIS IS REPORT 1 OF 2 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12122885 ↗
  • MalfunctionJul 31, 2020Material Twisted/Bent; Material Twisted/Bent

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT UNDERWENT FOR A SCREW REMOVAL PROCEDURE IN THE ILIAC PERFORMED ON (B)(6) 2020. DURING SCREW REMOVAL, A DRIVER¿S TIP STRIPPED AND REMAIN IN THE PATIENT BODY. THE SURGERY WAS COMPLETED WITHOUT DELAY REPORTED. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN) UNKNOWN SETSCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) T27 MODULAR DRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10351455 ↗

Other SCREWDRIVER devices

All SCREWDRIVER devices →

Sources and updates

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