THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems MT10-7540Recalls & reported problems
Choice Spine, LP · THUNDERBOLT,SCREW,POLYAXIAL,7.5X40 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840996110495), received between Mar 3, 2020 and Jan 29, 2024 — classified as 2 malfunctions.
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
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Fall1
- Nonunion/Delayed-union Bone Fracture1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 29, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ON (B)(6) 2024 PT WAS TAKEN TO SURGERY FOR CAGE REMOVAL AND PSF REVISION. ORIGINAL SURGERY (B)(6) 2022. A TIGER SHARK L WAS PLACED TODAY AFTER OLD CAGE WAS REMOVED. DURING THE PSF REVISION, ONE OF THE SCREWS WAS NOTED TO BE BROKEN (TULIP HEAD WAS BROKEN FROM SCREW SHAFT) AT LEVEL S1.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 18597671 ↗MalfunctionMar 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ORIGINAL SURGERY ON (B)(6) 2018. ONE YEAR POST OP PATIENT FELL ON SOME ICE. IN (B)(6) OF 2019 PATIENT CAME IN COMPLAINING OF PAIN. PATIENT XRAY TO SHOW THAT S1 SCREWS WERE BROKE. PATIENT WAS FUSED AT THE L4-S1 LEVELS. HARDWARE WAS REMOVED SUCCESSFULLY.
Patient problems: Fall; Pain
MAUDE report 9782290 ↗
Other Orthosis, spinal pedicle fixation, for degenerative disc disease devices
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- 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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