M.U.S.T. Midline Cortical (MC) Screw System 03.58.244Recalls & reported problems

Medacta International SA · MUST MC Screw Ø6x40 cannulated · Class 2 · Implant

All models of M.U.S.T. Midline Cortical (MC) Screw System (17)

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

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630971293564), received between Apr 5, 2024 and Nov 18, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (3 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

Fracture3

Patient problems

Implant Pain2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

InjuryNov 18, 2025Fracture; Fracture
PATIENT UNDERWENT SURGERY FOR VERTEBRAL FUSION L3-L5. 6 MONTHS AFTER PRIMARY THE PATIENT REPORTED PAIN. SURGEON PROCEEDED WITH REVISION AND FOUND 3 BROKEN SCREWS (L3-L4 RIGHT SIDE AND L5 ON THE LEFT SIDE). BREAKAGE OCCURRED AT THE BASE OF THE TULIP IN ALL SCREWS. IT WAS REPORTED THAT PATIENT'S BONE WAS ARTHRITIC AND THAT VERTEBRAL FUSION FAILED. CONSTRUCT WAS REVISED, SURGEON REPLACED THE SCREW IN L3-L5 ON THE RIGHT SIDE, REMOVED THE SCREW FROM LEFT L5 WHICH WAS NOT REPLACES, AND ADDED A SCREW IN LEFT S1.
Patient problems: Implant Pain
MAUDE report 23583105 ↗
InjuryMay 23, 2025Fracture; Fracture
PATIENT UNDERWENT PRIMARY SURGERY AT L4-L5 (PLIF, CBT TRAJECTORY). MYSPINE CASE CODE: H-SUG-OPS-RS-24061941. REVISION SURGERY PERFORMED AT ABOUT 2 MONTHS FROM PRIMARY DUE TO PAIN, CAUSE OF PAIN WAS IDENTIFIED AS A COLLAPSED L5 VERTEBRA. DURING SURGERY THE LEFT L5 PEDICLE SCREW WAS FOUND BROKEN AROUND THE SCREW HEAD. THE RIGHT L5 PEDICLE SCREW WAS NOT BROKEN. THE FIXATION RANGE WAS EXTENDED FROM L4 TO S2 WITH THE ADDITION OF A SCREW IN L4. NO PATIENT FALLS WERE REPORTED AFTER THE PRIMARY SURGERY.
Patient problems: Implant Pain
MAUDE report 22076622 ↗
MalfunctionApr 5, 2024Fracture; Fracture
THE SET SCREW OF MUST MC SCREW Ø6X40 CANNULATED CRACKED DURING FINAL TIGHTENING. THE SET SCREW COULD NOT BE DISENGAGED, SO THE SURGEON CUT AND REMOVED THE ROD, REVISED THE PEDICLE SCREW AND ENGAGED A NEW ROD. THERE WAS 20 MIN OF DELAY (TOTAL SURGERY TIME 3 HOURS).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 19049140 ↗

Device details

UDI-DI	`07630971293564`
Brand	M.U.S.T. Midline Cortical (MC) Screw System
Model	03.58.244
Company	Medacta International SA
Product code	NKB · Thoracolumbosacral Pedicle Screw System
Class	Class 2
FDA submission	K210427
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 26, 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.

Other Thoracolumbosacral Pedicle Screw System devices

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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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