Response 5.5/6.0 Spine System 01-1003-6035Recalls & reported problems
Orthopediatrics Corp. · PEDICLE SCREW DRIVER · 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 00841132122549), received between Oct 29, 2024 and Nov 20, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Unintended Movement” (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. 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
- Unintended Movement2
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.
MalfunctionNov 20, 2025Unintended Movement; Unintended Movement
DURING THE RECENT CASE, REP ENCOUNTERED A SIGNIFICANT WOBBLE ISSUE THAT LED TO THE DISCOVERY OF A NEW DISTAL TIP ENGAGEMENT CONCERN. REPRESENTATIVE SPENT APPROXIMATELY 30 MINUTES OR MORE AT THE BACK TABLE, TESTING WITH 3-4 DIFFERENT DRIVERS AND LOADING SCREWS. THERE WAS NO VISIBLE DEGRADATION OR DAMAGE TO ANY DISTAL TIPS, AND THE SCREWS APPEARED TO BE IN GOOD CONDITION. DESPITE THIS, THE ISSUE SLOWED THE CASE CONSIDERABLY AND INTRODUCED UNNECESSARY STRESS AND FRUSTRATION FOR THE SURGICAL TEAM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23607407 ↗MalfunctionOct 29, 2024Unintended Movement; Unintended Movement
A VERY CLEAR TOGGLE OF THE POLY AND UNIAXIAL SCREW ON THE SCREW DRIVER ON INSERTION OF THE SCREW INTO THE PEDICLE. REP WAS SCRUBBED AND ASSISTING, LOADED ALL THE SCREWS. EVEN UNDER LOW RESISTANCE , THE SCREWS WERE SKIVING OFF. CASUED A DELAY OF GREATER THAN 30MINS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20561785 ↗
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 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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