M.U.S.T. Reduction Pedicle Screws 03.50.732Recalls & reported problems
Medacta International SA · Reduction Pedicle Screw 7x50 mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030846977), received between Jun 1, 2021 and Jun 1, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Integrity Problem” (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
- Material Integrity Problem1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 1, 2021Material Integrity Problem; Material Integrity Problem
DURING THE PRIMARY SPINE CASE WHEN THE SURGEON INSERTED THE MUST PEDICLE SCREWS FROM T08 TO S02 USING THE MYSPINE GUIDES, THE ROD TO CONNECT ALL THE SCREWS, AND THE SET SCREW INTO EACH SCREW, DURING FINAL TIGHTENING, ONE OF THE SCREW FLANGE (CONTAINING THE ROD AND SET SCREW) DEFORMED AND A FRAGMENT OF THE TULIP POPPED OFF THE SCREW SHAFT. THE SURGEON HAD TO REMOVE THE SET SCREWS, REMOVED THE ROD, REMOVED THE AFFECTED SCREW, REPLACED THE BROKEN SCREW. THERE WAS A 1 HOUR AND 30-MINUTE DELAY AND ADDITIONAL ANESTHESIA WAS ADMINISTERED.
Patient problems: Failure of Implant
MAUDE report 11912724 ↗
Other Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease devices
- EXPEDIUM VERSE 199721000Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease387 reports
- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 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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