M.U.S.T. Midline Cortical (MC) Screw SystemRecalls & reported problems across all models
Medacta International SA · 17 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls
- 0
We found 17 models of M.U.S.T. Midline Cortical (MC) Screw System by Medacta International SA in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Apr 5, 2022 and Sep 9, 2026 — classified as 21 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Fracture” (9 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported M.U.S.T. Midline Cortical (MC) Screw System problems
Device problems
- Adverse Event Without Identified Device or Use Problem9
- Fracture9
- Appropriate Device Problem Term/Code Not Available4
- Loosening of Implant Not Related to Bone-Ingrowth2
- Malposition of Device2
- Difficult to Insert1
- Migration1
- Osseointegration Problem1
Patient problems
- Bone Fracture(s)10
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available5
- No Clinical Signs, Symptoms or Conditions5
- Implant Pain3
- Aseptic loosening2
- Pain2
M.U.S.T. Midline Cortical (MC) Screw System models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- M.U.S.T. Midline Cortical (MC) Screw System 03.58.244Thoracolumbosacral Pedicle Screw System3 reports
- M.U.S.T. Midline Cortical (MC) Screw System 03.58.264Thoracolumbosacral Pedicle Screw System3 reports
- M.U.S.T. Midline Cortical (MC) Screw System 03.58.265Thoracolumbosacral Pedicle Screw System3 reports
- M.U.S.T. Midline Cortical (MC) Screw System 03.58.234Thoracolumbosacral Pedicle Screw System2 reports
- M.U.S.T. Midline Cortical (MC) Screw System 03.58.246Thoracolumbosacral Pedicle Screw System2 reports
- M.U.S.T. Midline Cortical (MC) Screw System 03.58.263Thoracolumbosacral Pedicle Screw System2 reports
- M.U.S.T. Midline Cortical (MC) Screw System 03.58.225Thoracolumbosacral Pedicle Screw System1 report
- M.U.S.T. Midline Cortical (MC) Screw System 03.58.235Thoracolumbosacral Pedicle Screw System1 report
- M.U.S.T. Midline Cortical (MC) Screw System 03.58.236Thoracolumbosacral Pedicle Screw System1 report
- M.U.S.T. Midline Cortical (MC) Screw System 03.58.242Thoracolumbosacral Pedicle Screw System1 report
- M.U.S.T. Midline Cortical (MC) Screw System 03.58.243Thoracolumbosacral Pedicle Screw System1 report
- M.U.S.T. Midline Cortical (MC) Screw System 03.58.245Thoracolumbosacral Pedicle Screw System1 report
- M.U.S.T. Midline Cortical (MC) Screw System 03.58.254Thoracolumbosacral Pedicle Screw System1 report
- M.U.S.T. Midline Cortical (MC) Screw System 03.58.443Thoracolumbosacral Pedicle Screw System1 report
- M.U.S.T. Midline Cortical (MC) Screw System 03.58.634Thoracolumbosacral Pedicle Screw System1 report
- M.U.S.T. Midline Cortical (MC) Screw System 03.58.644Thoracolumbosacral Pedicle Screw System1 report
- M.U.S.T. Midline Cortical (MC) Screw System 03.58.663Thoracolumbosacral Pedicle Screw System1 report
Recent M.U.S.T. Midline Cortical (MC) Screw System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
Spinal fixation was performed at L4-L5. The L5 pedicle fractured after the rod was inserted. The trajectory was changed from CBT to PS, and the same screw was reinserted. As the trajectory was altered, the required rod length changed, and a new rod (50 mm) was used. No critical delay.The quality of the patient`s bone was unknown.
Patient problems: Bone Fracture(s)
MAUDE report 50692269 ↗InjuryApr 9, 2026Loosening of Implant Not Related to Bone-Ingrowth
AT ABOUT 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO TWO SCREWS THAT WERE LOOSE AT THE L2 LEVEL. THE SURGEON OBSERVED THAT THERE WAS POOR BONE QUALITY. THE SURGEON REMOVED THE TWO SCREWS AND EXTENDED THE RODS IN THE CONSTRUCT UP TO THE T12 LEVEL, BUT LEFT SCREWS OUT OF THE L2 LEVEL DUE TO THE BONE QUALITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Aseptic loosening
MAUDE report 24826099 ↗InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem
DURING L2D SAI FIXATION SURGERY PERFORMED VIA AN OPEN APPROACH, A 7 MM X 35 MM SCREW WAS INSERTED INTO L4 (LEFT) FOLLOWING TAPPING WITH A 6 MM TAP. DURING INSERTION, A BONY FRACTURE OCCURRED, CAUSING THE SCREW TO LOOSEN AND BACK OUT. AS STABLE SCREW FIXATION AT THIS LEVEL WAS NO LONGER FEASIBLE, THE LEVEL WAS SKIPPED, THE ROD WAS SECURED, AND THE PROCEDURE WAS COMPLETED.
Patient problems: Bone Fracture(s)
MAUDE report 24558200 ↗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 ↗InjuryNov 28, 2025Malposition of Device; Malposition of Device
ON (B)(6) 2025, THE PATIENT HAD PRIMARY SPINE SURGERY L3-L5. ON (B)(6) 2025, THE PATIENT REPORTED PAIN AND DURING REVISION SURGERY, THE SURGEON DISCOVERED THAT VERTEBRAL FUSION HAD FAILED AND 3 SCREWS WERE BROKEN. THE SURGEON WAS ABLE TO REMOVE ALL THE BROKEN SCREWS AND REPLACE THEM. ALSO, CONSTRUCT WAS EXPANDED WITH A SCREW IN LEFT S1. THE SURGERY WAS COMPLETED SUCCESSFULLY ((B)(4)). PRESENTLY, ON (B)(6) 2025, THE SURGEON DETERMINED THE S1 SCREW WAS IMPLANTED TOO LOW AND NEEDED RE-ADJUSTMENT. THE SURGERY INVOLVED NO NEW MEDACTA IMPLANTS, BUT DID RESULT IN TAKING OUT THE SET SCREWS, THE ROD AND BACK OUT THE LEFT S1 SCREW TO RE-ADJUST ITS LOCATION AND THEN RE-IMPLANT THE SAME ROD AND SET SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23669493 ↗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 ↗InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SPINAL FIXATION WAS SCHEDULED TO BE PERFORMED AT L3-L5. DURING THE FIRST STEP, THE SURGEON TRIED TO INSERT THE PEDICLE SCREW AT L3, BUT THE BONE CRACKED. THE FIXATION RANGE WAS CHANGED TO L4-L5, ONLY DECOMPRESSION WAS PERFORMED AT L3. NOTE: THE SCREW CAUSING THE BONE FRACTURE WASN'T FINALLY IMPLANTED.
Patient problems: Bone Fracture(s)
MAUDE report 23424431 ↗MalfunctionJul 16, 2025Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem
PLIF SURGERY WAS PERFORMED AT L3-L5 WITH THE MYSPINE MC GUIDE ON (B)(6) 2025. THE DAY AFTER THE SURGERY, CT SCAN WAS TAKEN AND IT APPEARED THAT THE ENTIRE GUIDE HAD BEEN PLACED TILTED TO THE LEFT (MEANING THAT THE TRAJECTORY OF THE SCREWS ARE VERY DIFFERENT FROM THE PLANNING). NO FITTING ISSUE WITH THE GUIDES WAS EXPERIENCED DURING SURGERY. THE PATIENT IS CURRENTLY ASYMPTOMATIC, AND THE SURGEON IS CURRENTLY WAITING FOR THE BONE FUSION. WEAK BONE QUALITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22520976 ↗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 ↗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 ↗InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SPINAL FIXATION WAS PERFORMED AT L4-L5 WITH MYSPINE MC GUIDE. WHEN THE SURGEON TRIED TO INSERT THE PEDICLE SCREW (5.5MM X 40MM) AT RIGHT SIDE OF L5, THE PATIENT BONE BROKE. PATIENT'S BONE QUALITY WEAK. HOLE PREPARATION: 5MM UNDER TAP 6MM SAME TAP. THE SURGEON CHANGED THE TRAJECTORY AND INSERTED THE PEDICLE SCREW (5.5MM X 35MM). THE REASON FOR CHANGING THE SCREW LENGTH WAS THAT THE TRAJECTORY WAS CHANGED, RESULTING IN A SHORTER TRAJECTORY.
Patient problems: Bone Fracture(s)
MAUDE report 21908585 ↗InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE SURGEON CREATED THE SCREW HOLE USING THE MYSPINE MC GUIDE. A CRACK IN THE BONE OCCURRED WHILE INSERTING THE PEDICLE SCREW (6MM X 05MM) AT THE RIGHT SIDE OF L5. THE SURGEON USED ANOTHER SCREW AND CHANGED THE TRAJECTORY PLACING THE SCREW FREEHAND (6MM X 35MM). BONE QUALITY NORMAL. THE HOLE WAS PREPARED BY DRILLING, UNDER TAPPING, AND INLINE TAPPING, AND THEN THE SCREW WAS INSERTED. DUE TO THIS EVENT, THE SURGERY WAS EXTENDED TO ABOUT 15 MINUTES (NEEDED TO PREPARE THE NEW TRAJECTORY). THE SURGERY LASTED 4 HOURS.
Patient problems: Bone Fracture(s)
MAUDE report 20923087 ↗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 ↗InjuryOct 4, 2024Migration; Migration
THE PATIENT UNDERGONE PRIMARY SURGERY ON THE (B)(6) 2024. REVISION SURGERY WILL BE PERFORMED DUE TO A MEDIAL DEVIATION OF L5 PEDICLE SCREW. NO ADDITIONAL INFO AVAILABLE AT NOW.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 20369755 ↗InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SPINAL FIXATION WAS PERFORMED AT L4-S WITH MYSPINE MC GUIDE. AFTER THE TAPPING 6MM(UNDER) AT RIGHT SIDE OF S1, DURING THE INSERTION OF THE PEDICLE SCREW, THE PATIENT BONE BROKE. THE SURGEON CHANGED THE TRAJECTORY AND REPLACED THE SCREW WITH A NEW ONE (6 X 40MM). THE SURGERY WAS COMPLETED SUCCESSFULLY. THE BONE IS REPORTED TO BE SCLEROTIC.
Patient problems: Bone Fracture(s)
MAUDE report 20154521 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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