EXPEDIUM 179722865Recalls & reported problems

Medos International Sàrl · EXPEDIUM SPINE SYSTEM DI POLYAXIAL SCREW 5.5 x 8 x 65mm · Class 2 · Implant

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034071015), received between Apr 15, 2024 and Apr 15, 2024 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Reports received per month

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

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1

Patient problems

Unspecified Infection1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryApr 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REMOVAL OF HARDWARE DUE TO INFECTION ON (B)(6) 2024. FOUR SCREWS, 3 LATERAL CONNECTORS, AND 7 SET SCREWS WERE REMOVED. NO FURTHER DETAILS ARE AVAILABLE. THIS REPORT INVOLVES ONE UNK - SCREWS: EXPEDIUM. THIS IS REPORT 2 OF 4 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS RELATED TO THIS EVENT ARE CAPTURED IN (B)(4). ADDITIONALLY, (B)(4) CAPTURES AN INSTRUMENT MALFUNCTION THAT OCCURRED DURING THE REMOVAL SURGERY.
Patient problems: Unspecified Infection
MAUDE report 19106980 ↗

Device details

UDI-DI	`10705034071015`
Brand	EXPEDIUM
Model	179722865
Company	Medos International Sàrl
Product code	NKB · Orthosis, spinal pedicle fixation, for degenerative disc disease
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 11, 2024

Device type (GMDN): Spinal bone screw, non-bioabsorbable

A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

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EXPEDIUM VERSE 199721001S
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All Orthosis, spinal pedicle fixation, for degenerative disc disease devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.