VADER Pedicle System, Screw, Carbon/PEEK, Polyax., Fen., Ø 6.5 x 50 mm 16-6022-56550Recalls & reported problems
icotec AG · VADER Pedicle System, Screw, Carbon/PEEK, Polyax., Fen., Ø 6.5 x 50 mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07640164844756), received between Jun 2, 2026 and Jun 2, 2026 — classified as 1 injury.
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
- Break1
Patient problems
- Back pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 2, 2026Break
A PATIENT IN SWITZERLAND WAS TREATED ON (B)(6) 2024 WITH 4 PEDICLE SCREWS T9 AND T11 WITH A TUMOR BEEING PRESENT AT T10. THE PATIENT NOTICED INCREASING PAIN (DATE BETWEEN ON (B)(6) 2025 AND ON (B)(6) 2026). AT THE HOSPITAL, IT WAS DIAGNOSED THAT T10 HAD COLLAPSED. DURING IMAGING IT WAS ADDITIONALLY NOTICED THAT THE SCREW T11 LEFT WAS LOOSE. A REVISION SURGERY WAS PLANNED AND CONDUCTED ON (B)(6) 2026 WHERE IT WAS NOTICED THAT THE SCREW T11 RIGHT HAS BROKEN. DURING THE REVISION SURGERY THE SURGEON REPLACED THE SCREW IN T11 LEFT AND TREATED AN ADDITIONAL LEVEL T12 WITH A SCREW LEFT AND RIGHT. THE SURGEON DECIDED TO LEAVE THE BROKEN OFF SHAFT OF THE SCREW IN T11 RIGHT IN THE PATIENT.
Patient problems: Back pain
MAUDE report 25356813 ↗
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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