Armada 8448590Recalls & reported problems
Nuvasive, Inc. · ARM15T Screw, 8.5x90mm Iliac SL-Open · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517256492), received between Jan 5, 2017 and Jan 5, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 5, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
ON 12/12/2016 IT WAS REPORTED THAT DURING A THORACIC LUMBAR SURGERY ON (B)(6) 2016, THE TULIP HEAD OF ONE ILIAC SCREW DISENGAGED AND THE THREAD IN THE SHANK WAS STRIPPED. THE SCREW WAS LEFT IN THE PATIENT AND NO PATIENT INJURY WAS REPORTED. THE SURGEON HAS ELECTED TO MONITOR THE PATIENT. NO REVISION SURGERY IS SCHEDULED AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 6226208 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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