NILE™ Alternative Fixation System 5416-F04730-SGRecalls & reported problems
VB Spine LLC · Band Size 4 mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888857000025), received between Nov 24, 2015 and Nov 15, 2016 — classified as 1 injury, 1 malfunction.
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.
Most reported problems
Device problems
- Break1
- Fracture1
Patient problems
- No Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 15, 2016Fracture; Fracture
IT WAS REPORTED TO K2M, INC. ON 10/16/2016 THAT A SURGERY TOOK PLACE ON (B)(6) 2016 IN WHICH A NILE BAND TORE.
Patient problems: No Information
MAUDE report 6101513 ↗InjuryNov 24, 2015Break
IT WAS REPORTED TO K2M, INC. ON (B)(6) 2015 THAT A REVISION SURGERY TOOK PLACE IN WHICH 5 BROKEN 4MM NILE BANDS WERE REMOVED. THE PATIENT REPORTEDLY HAD 5 NILE BANDS BREAK APPROXIMATELY 3 MONTHS POST-OP. REVISION SURGERY TOOK PLACE (B)(6) 2015.
Patient problems: No Information
MAUDE report 5245904 ↗
Other Bone fixation cerclage, sublaminar devices
- TRANSLACE™ Spinal Tethering System 8219500Medtronic Sofamor Danek, Inc. · Bone fixation cerclage, sublaminar11 reports
- VersaTie 86101245Nuvasive, Inc. · Bone fixation cerclage, sublaminar4 reports
- LIGAPASS B08110005Medicrea International · Bone Fixation Cerclage, Sublaminar3 reports
- KARMA 75035-175Spinal Elements, Inc. · Bone Fixation Cerclage, Sublaminar3 reports
- JAZZ LOCKImplanet · Bone Fixation Cerclage, Sublaminar3 reports
- VersaTie 8510260Nuvasive, Inc. · Bone fixation cerclage, sublaminar3 reports
- VersaTie 8450001Nuvasive, Inc. · Bone fixation cerclage, sublaminar2 reports
- TRANSLACE™ Spinal Tethering System 8205300Medtronic Sofamor Danek, Inc. · Bone fixation cerclage, sublaminar2 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.
How reports and recalls are matched · Editorial policy · Report an error on this page