M.U.S.T. Pedicle Screw System 03.56.503Recalls & reported problems

Medacta International SA · MUST MC Cross-Connector 19-29mm adjustable · Class 2 · Implant

All models of M.U.S.T. Pedicle Screw System (20)

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

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 07630040728799), received between Feb 9, 2023 and Feb 9, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 18, 2026.

Most reported problems

Device problems

Loosening of Implant Not Related to Bone-Ingrowth1
Material Deformation1

Patient problems

Insufficient Information1

Recent adverse event reports

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

InjuryFeb 9, 2023Material Deformation; Loosening of Implant Not Related to Bone-Ingrowth; Material Deformation; Loosening of Implant Not Related to Bone-Ingrowth
PRIMARY SURGERY PERFORMED 6 MONTHS AGO (JULY 2022), L4-L5-S1 TLIF. SIX MONTHS LATER, L4-L5 PRESENTED BONY FUSION, HOWEVER, L5-S1 RESULTED IN PSEUDOARTHROSIS WITH S1 SCREW LOOSENING. THE CROSS-CONNECTOR WAS LOCATED AT L4-L5. AT THE REVISION SURGERY, THE CROSS-CONNECTOR WAS NOT STABLE ALREADY BEFORE REMOVING THE SET SCREWS. L4 AND L5 PEDICLE SCREWS WERE OK WITHOUT ANY SIGNS OF LOOSENING AND L4-L5 WAS COMPLETELY FUSED, BUT THE CROSS-CONNECTOR AT L4-L5 SHOWED LOOSENING; WHILE IN L5-S1 WAS NON-UNION AND S1 SCREWS WERE LOOSE.
Patient problems: Insufficient Information
MAUDE report 16332042 ↗

Device details

UDI-DI	`07630040728799`
Brand	M.U.S.T. Pedicle Screw System
Model	03.56.503
Company	Medacta International SA
Product code	NKB · Thoracolumbosacral Pedicle Screw System
Class	Class 2
FDA submission	K193365
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 17, 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.

Other Thoracolumbosacral Pedicle Screw System devices

EXPEDIUM VERSE 199721000
Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease
387 reports
Sequoia® 3301-1
Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease
184 reports
CD HORIZON® Spinal System 8590855
Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease
179 reports
Vitality® 07.02011.001
Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease
3 recalls0 reports
EXPEDIUM VERSE 199721001S
Medos International Sàrl · Thoracolumbosacral pedicle screw system
124 reports
LineSider LS-N6SA7550
Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System
2 recalls1 report
LineSider LS-N6SA6545
Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System
2 recalls0 reports
EXPEDIUM VERSE 199721000S
Medos International Sàrl · Thoracolumbosacral pedicle screw system
97 reports

All Thoracolumbosacral Pedicle Screw 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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