EXPEDIUM 279702050Recalls & reported problems

Medos International Sàrl · EXPEDIUM SPINE SYSTEM SCREWDRIVER T20 · Class 1

All models of EXPEDIUM (291)

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

Quick summary

This Medos Expedium spine screwdriver has 107 reports, no deaths and 2 injuries. Many reports describe the screwdriver head stripping or the shaft bending during use, and some describe pieces breaking off. Reports rose from 7 in the prior 12 months to 26 in the latest 12 months. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 107
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 107 adverse event reports that list this exact device (DI 10705034198453), received between Feb 13, 2018 and Dec 5, 2025 — classified as 2 injuries, 105 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (70 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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Material Twisted/Bent70
Break28
Material Deformation9
Device-Device Incompatibility3
Entrapment of Device3
Defective Device1
Material Fragmentation1
Material Integrity Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions88
No Consequences Or Impact To Patient12
Foreign Body In Patient5
Insufficient Information2
Not Applicable2
Injury1
No Code Available1
No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 25 most recent of 107 reports, in the reporter's own words as published by the FDA.

MalfunctionDec 5, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED ON (B)(6) 2025 SCREWDRIVER HEAD STRIPPED DUE TO USE. THERE WAS NO PATIENT INVOLVEMENT. ON (B)(4) AND (B)(4) RELATED TO EACH OTHER. THIS (B)(4) WAS CREATED TO CAPTURE THE ADDITIONAL IPS FROM (B)(4). ON (B)(4) CAPTURES T20 SCREWDRIVER SHAFT (279702050/GM3708302) (X10). ON (B)(4) CAPTURES T20 SCREWDRIVER SHAFT (279702050/GM3708302) (X6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23733455 ↗
MalfunctionDec 5, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED ON 17 NOVEMBER, 2025 SCREWDRIVER HEAD STRIPPED DUE TO USE. THERE WAS NO PATIENT INVOLVEMENT. (B)(4) RELATED TO EACH OTHER. THIS (B)(4) WAS CREATED TO CAPTURE THE ADDITIONAL IPS FROM (B)(4). (B)(4) CAPTURES T20 SCREWDRIVER SHAFT (279702050/GM3708302) (X10). (B)(4) CAPTURES T20 SCREWDRIVER SHAFT (279702050/GM3708302) (X6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23733454 ↗
MalfunctionDec 5, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED ON 17 NOVEMBER, 2025 SCREWDRIVER HEAD STRIPPED DUE TO USE. THERE WAS NO PATIENT INVOLVEMENT. (B)(4) AND (B)(4) RELATED TO EACH OTHER. THIS (B)(4) WAS CREATED TO CAPTURE THE ADDITIONAL IPS FROM (B)(4). (B)(4) CAPTURES T20 SCREWDRIVER SHAFT (279702050/GM3708302) (X10). (B)(4) CAPTURES T20 SCREWDRIVER SHAFT (279702050/GM3708302) (X6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23733449 ↗
MalfunctionDec 5, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED ON (B)(6) 2025 SCREWDRIVER HEAD STRIPPED DUE TO USE. THERE WAS NO PATIENT INVOLVEMENT. (B)(4) RELATED TO EACH OTHER. THIS (B)(4) WAS CREATED TO CAPTURE THE ADDITIONAL IPS FROM (B)(4). (B)(4) CAPTURES T20 SCREWDRIVER SHAFT (279702050/GM3708302) (X10). (B)(4) CAPTURES T20 SCREWDRIVER SHAFT (279702050/GM3708302) (X6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23733448 ↗
MalfunctionDec 5, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED ON 17 NOVEMBER, 2025 SCREWDRIVER HEAD STRIPPED DUE TO USE. THERE WAS NO PATIENT INVOLVEMENT. (B)(4) RELATED TO EACH OTHER. THIS (B)(4) WAS CREATED TO CAPTURE THE ADDITIONAL IPS FROM (B)(4). (B)(4) CAPTURES; T20 SCREWDRIVER SHAFT (279702050/GM3708302) (X10). (B)(4) CAPTURES; T20 SCREWDRIVER SHAFT (279702050/GM3708302) (X6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23733447 ↗
MalfunctionDec 5, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED ON 17 NOVEMBER, 2025 SCREWDRIVER HEAD STRIPPED DUE TO USE. THERE WAS NO PATIENT INVOLVEMENT. (B)(4) RELATED TO EACH OTHER. THIS (B)(4) WAS CREATED TO CAPTURE THE ADDITIONAL IPS FROM (B)(4). (B)(4) CAPTURES T20 SCREWDRIVER SHAFT (279702050/GM3708302) (X10). (B)(4) CAPTURES T20 SCREWDRIVER SHAFT (279702050/GM3708302) (X6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23733440 ↗
MalfunctionDec 4, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THE SCREWDRIVER HEAD STRIPPED DUE TO USE. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23717160 ↗
MalfunctionDec 4, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THE SCREWDRIVER HEAD STRIPPED DUE TO USE. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23717159 ↗
MalfunctionDec 4, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THE SCREWDRIVER HEAD STRIPPED DUE TO USE. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23717130 ↗
MalfunctionDec 4, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THE SCREWDRIVER HEAD STRIPPED DUE TO USE. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23717118 ↗
MalfunctionDec 4, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THE SCREWDRIVER HEAD STRIPPED DUE TO USE. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23717104 ↗
MalfunctionDec 4, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THE SCREWDRIVER HEAD STRIPPED DUE TO USE. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23717079 ↗
MalfunctionDec 4, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THE SCREWDRIVER HEAD STRIPPED DUE TO USE. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23717016 ↗
MalfunctionDec 4, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THE SCREWDRIVER HEAD STRIPPED DUE TO USE. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23717013 ↗
MalfunctionDec 4, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THE SCREWDRIVER HEAD STRIPPED DUE TO USE. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23717006 ↗
MalfunctionDec 4, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THE SCREWDRIVER HEAD STRIPPED DUE TO USE. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23717001 ↗
MalfunctionNov 19, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED ON NOVEMBER 3, 2025 THE INSTRUMENTS BECAME STRIPPED DUE TO OVERUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23594223 ↗
MalfunctionNov 19, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED ON NOVEMBER 3, 2025 THE INSTRUMENTS BECAME STRIPPED DUE TO OVERUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23594222 ↗
MalfunctionNov 19, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED ON(B)(6) 2025 THE INSTRUMENTS BECAME STRIPPED DUE TO OVERUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23594221 ↗
MalfunctionNov 19, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED ON NOVEMBER 3, 2025 THE INSTRUMENTS BECAME STRIPPED DUE TO OVERUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23594219 ↗
MalfunctionNov 19, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED ON (B)(6) 2025 THE INSTRUMENTS BECAME STRIPPED DUE TO OVERUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23594218 ↗
MalfunctionNov 19, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED (B)(6) 2025 THE INSTRUMENTS BECAME STRIPPED DUE TO OVERUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23594216 ↗
MalfunctionNov 19, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED ON NOVEMBER 3, 2025 THE INSTRUMENTS BECAME STRIPPED DUE TO OVERUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23594215 ↗
MalfunctionNov 19, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED ON NOVEMBER 3, 2025 THE INSTRUMENTS BECAME STRIPPED DUE TO OVERUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23594212 ↗
MalfunctionNov 19, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED ON NOVEMBER 3, 2025 THE INSTRUMENTS BECAME STRIPPED DUE TO OVERUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23594211 ↗

Device details

UDI-DI	`10705034198453`
Brand	EXPEDIUM
Model	279702050
Company	Medos International Sàrl
Product code	HXX · SCREWDRIVER
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 5, 2023

Device type (GMDN): Surgical screwdriver, reusable

A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

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All SCREWDRIVER devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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