M.U.S.T. Midline Cortical (MC) Screw System 03.58.265Recalls & reported problems

Medacta International SA · MUST MC Screw Ø7x45 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: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630971293779), received between Oct 23, 2024 and Feb 16, 2026 — classified as 1 injury, 2 malfunctions.

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
Loosening of Implant Not Related to Bone-Ingrowth1

Patient problems

Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Aseptic loosening1
Implant Pain1
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

InjuryFeb 16, 2026Fracture; Loosening of Implant Not Related to Bone-Ingrowth
IN (B)(6) 2023, PLIF (L3-L4) WAS PERFORMED FOR EXTENSION FIXATION OF L4-L5 (PLIF). MUST MC SCREW AND COMPETITOR`S CAGE (MDM) WERE USED. PRESENTLY, REVISION SURGERY WAS PERFORMED DUE TO LOOSENING AND BREAKAGE OF THE LEFT L4 SCREW. THE BROKEN SCREW WAS REMOVED, THE CAGE WAS REINSERTED, AND THE RE-FIXATION (CEMENT SCREW INSERTION, L2-L5) WAS PERFORMED. PATIENT`S BONE QUALITY REPORTED TO BE WEAK.NO TRAUMATIC EVENT REPORTED.
Patient problems: Aseptic loosening
MAUDE report 24343886 ↗
MalfunctionJul 11, 2025Fracture; Fracture
REVISION SURGERY FOR MUST MC SCREW BROKEN IN S1. THE PATIENT HAVE A L4-S1 SPINE CONSTRUCT. DATE OF PRIMARY AND REVISION UNKNOWN. NO FURTHER INFO AVAILABLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 22477671 ↗
MalfunctionOct 23, 2024Fracture; Fracture
PRIMARY SURGERY WAS PERFORMED AT L4-S WITH MUST MC AND MYSPINE MC GUIDE ON (B)(6) 2024. THE PATIENT HAD PAIN AND HAD A VISIT IN EARLY (B)(6) 2024. IT WAS DISCOVERED THAT THE BOTH SIDES OF THE S1 SCREWS WERE BROKEN IN THE X-RAY. REVISION SURGERY WAS PERFORMED ON (B)(6) 2024. ALL IMPLANTS WERE REMOVED, AND REPLACED WITH COMPETITOR'S PRODUCTS. THE TIP OF THE BROKEN SCREWS REMAINED IN THE PATIENT'S BODY.
Patient problems: Implant Pain
MAUDE report 20512110 ↗

Device details

UDI-DI	`07630971293779`
Brand	M.U.S.T. Midline Cortical (MC) Screw System
Model	03.58.265
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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EXPEDIUM VERSE 199721000S
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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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