VADER Pedicle System, Screw, Carbon/PEEK, Polyax., Fen., Ø 5.5 x 45 mm 16-6022-55545Recalls & reported problems
icotec AG · VADER Pedicle System, Screw, Carbon/PEEK, Polyax., Fen., Ø 5.5 x 45 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 07640164844671), received between Sep 11, 2025 and Sep 11, 2025 — classified as 1 injury.
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
Patient problems
- Implant Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PATIENT IN SWITZERLAND WAS TREATED WITH AN ICOTEC PEDICLE SCREW SYSTEM (8 PEDICLE SCREWS). THE PATIENT NOTICED INCREASING PAIN. IMAGING REVEALED A POSSIBLE INFECTION IN THE LOCATION OF THE IMPLANTS AND LOOSENED PEDICLE SCREWS. A REVISION SURGERY WAS REQUIRED. DURING THE REVISION SURGERY (B)(6) 2025) ALL SCREWS WERE REMOVED WHEREBY ONE SCREW BROKE.
Patient problems: Implant Pain
MAUDE report 23028787 ↗
Other Bone Cement, Posterior Screw Augmentation devices
- VIPER 186727645Medos International Sàrl · bone cement, posterior screw augmentation3 deaths27 reports
- VIPER 186727745Medos International Sàrl · bone cement, posterior screw augmentation23 reports
- EXPEDIUM VERSE 199723645Medos International Sàrl · bone cement, posterior screw augmentation21 reports
- EXPEDIUM VERSE 199723745Medos International Sàrl · bone cement, posterior screw augmentation13 reports
- VIPER 186727640Medos International Sàrl · bone cement, posterior screw augmentation2 deaths11 reports
- VIPER 186727850Medos International Sàrl · bone cement, posterior screw augmentation9 reports
- EXPEDIUM VERSE 199723435Medos International Sàrl · bone cement, posterior screw augmentation6 reports
- EXPEDIUM VERSE 199723535Medos International Sàrl · bone cement, posterior screw augmentation4 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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