EXPEDIUM 186172640Recalls & reported problems

Depuy Spine, LLC · EXPEDIUM SPINE SYSTEM EXTENDED TANDEM CONNECTOR 4.5 - 4.5 x 40mm · Class 2 · Implant

All models of EXPEDIUM (29)

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034109121), received between Mar 19, 2022 and Mar 19, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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.

Most reported problems

Device problems

Break1
Material Twisted/Bent1

Patient problems

Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1

Recent adverse event reports

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

MalfunctionMar 19, 2022Break; Material Twisted/Bent; Break; Material Twisted/Bent
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON WAS PERFORMING A LENGTHENING ON A PATIENT AND THE TWO EXTENDED CONNECTORS IMPLANTED. THE EXPEDIUM 4.5 SET SCREW FROM THE CONNECTOR STRIPPED AND BROKE INSIDE THE CONNECTOR. THERE WAS A TWENTY MINUTE SURGICAL DELAY. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13827940 ↗

Device details

UDI-DI	`10705034109121`
Brand	EXPEDIUM
Model	186172640
Company	Depuy Spine, LLC
Product code	PGM · Growing rod system
Class	Class 2
FDA submission	K141509
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): Bone-screw internal spinal fixation system connector

An implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.

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All Growing rod system 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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