IJS-ERecalls & reported problems

Skeletal Dynamics L.L.C. · Twin IJS-E, Assembly · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841506109138), received between Jun 7, 2024 and May 19, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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. 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

Fracture2
Material Twisted/Bent1

Patient problems

Failure of Implant2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionMay 19, 2026Fracture
AN IMPLANTED DOUBLE IJS-E (INTERNAL JOINT STABILIZER - ELBOW) BROKE AT THE BASE OF BOTH BOOMS, REQUIRING REVISION/REMOVAL SURGERY.
Patient problems: Failure of Implant
MAUDE report 25225469 ↗
MalfunctionJun 7, 2024Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent
AN IMPLANTED DOUBLE IJS-E (INTERNAL JOINT STABILIZER - ELBOW) BROKE AT THE BASE OF THE MEDIAL BOOM ARM EIGHT WEEKS FOLLOWING INTIAL IMPLANTATION, REQUIRING REVISION SURGERY.
Patient problems: Failure of Implant
MAUDE report 19487746 ↗

Device details

UDI-DI	`00841506109138`
Brand	IJS-E
Model	IJS
Catalog no.	IJS-DBL-BPA
Company	Skeletal Dynamics L.L.C.
Product code	OZI · Internal hinged elbow fixator
Class	Class 2
FDA submission	K153208
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	Jul 2, 2025

Device type (GMDN): Elbow stabilization implant

An implantable device consisting of multiple preassembled components designed to provide elbow joint stability, while allowing joint articulation, in cases of elbow instability (e.g., chronic dislocation) or following trauma. It consists of plates, screws, pin(s), and rod(s) intended for attachment to the humerus and the ulna. It is intended for explantation following healing. Disposable devices dedicated to implantation may be included with the implant.

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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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