Arx 175-147Recalls & reported problems
Life Spine, Inc. · ARX T25 POLYAXIAL SCREW DRIVER, CANNULATED · Class 2
Data updated Oct 13, 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 00190837073671), received between May 15, 2025 and Jun 23, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 23, 2025Fracture; Fracture
IT WAS STATED THAT, "THE CANNULATED DRIVER TIP SHEARED OFF WITHIN THE HEXALOBE OF THE BONE SCREW WHEN DR. CLARK WAS TRYING TO BURY THE ARX Ø10.5MM SAI SCREW INTO THE ILIUM. THE SCREW WITH THE FRACTURED DRIVERTIP WAS THEN REMOVED FROM THE PATIENT WITH ALL COMPONENTS RETRIEVED FROM THE PATIENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22310477 ↗MalfunctionMay 15, 2025Fracture; Fracture
IT WAS STATED THAT "THE INSTRUMENTS BROKE WITH NORMAL USE. ONE DRIVER LOCKED ON THE T-HANDLE WHILE IMPLANTING A SCREW AND THE OTHER DRIVER TIP BROKE WHILE IMPLANTING A SCREW. THEY WERE IMPLANTING THE FIRST SAI SCREW WHEN THE T-HANDLE SEIZED UP ON THE DRIVER AFTER THE SCREW BOTTOMED OUT AND THEY COULDN'T GET IT OFF. THE SECOND DRIVER WAS THEN USED TO IMPLANT A SECOND SAI SCREW AND AS IT BOTTOMED OUT, THE TIP OF THE DRIVER BROKE OFF. THEY WERE ABLE TO RETRIEVE THE PIECE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22030161 ↗
Other Thoracolumbosacral pedicle screw system 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page