M.U.S.T. MINI Polyaxial Screw 03.75.001Recalls & reported problems
Medacta International SA · Polyaxial Screw 3.5 x 12 Full thread + nut · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030863158), received between Apr 6, 2018 and Apr 2, 2026 — classified as 3 injuries.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Migration1
Patient problems
- Bone Fracture(s)1
- Insufficient Information1
- No Code Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem
BONE FRACTURE DURING C2D T3 FIXATION AT THE BASE OF THE RIGHT C4/C6 SCREWS. PEDICLE PREPARATION WAS CARRIED OUT USING THE MYSPINE GUIDE, FOLLOWED BY DECOMPRESSION AND SCREW INSERTION. AFTER THE INSERTION OF THE ROD INTO THE PEDICLE SCREW TULIP, A FRACTURE OCCURRED AND THE SCREWS WERE REMOVED. FIXATION AT THE AFFECTED LEVEL WAS SKIPPED, AND THE PROCEDURE WAS CONCLUDED. NO CRITICAL DELAY.
Patient problems: Bone Fracture(s)
MAUDE report 24762670 ↗InjuryMar 8, 2022Migration; Migration
DURING A FOLLOW-UP VISIT, 1 MONTH AFTER THE PRIMARY SURGERY, IT WAS DISCOVERED THAT THE IMPLANTED RIGHT ROD WAS DISPLACED TO THE CRANIO-CAUDAL SIDE. DURING THE REVISION SURGERY, IT WAS ALSO FOUND THAT THE SET SCREWS WERE LOOSE ON THE LEFT SIDE AS WELL, SO, ALL THE SCREWS AND RODS WERE REPLACED.
Patient problems: Insufficient Information
MAUDE report 13693886 ↗InjuryApr 6, 2018Break; Break
THE SURGEON HAD DIFFICULTY TO TIGHTEN THREE SET SCREWS INTO THE PEDICLE SCREW TULIPS. AFTER MANY ATTEMPTS, THE THREAD OF THE THREE SET SCREWS BROKE (LOTS THAT BROKE OFF ARE UNKNOWN, 18 SCREWS WERE USED). THREE NEW SET SCREWS WERE USED IN ORDER TO COMPLETE THE SURGERY.
Patient problems: No Code Available
MAUDE report 7402533 ↗
Other Appliance, Fixation, Spinal Interlaminal devices
- EXPEDIUM 179702000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL439 reports
- EXPEDIUM VERSE 199721001Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL227 reports
- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- Arsenal Deformity Spinal Fixation System 47127Alphatec Spine, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL66 reports
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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