Armada 8439560Recalls & reported problems
Nuvasive, Inc. · ARM15T Screw, 9.5x60mm Iliac SL-Closed · Class 2 · Implant
Data updated Oct 16, 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 00887517252654), received between Jan 7, 2016 and Mar 10, 2016 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Mechanical Problem1
- Misconnection1
Patient problems
- Failure of Implant2
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 10, 2016Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
ON (B)(6) 2015 A (B)(6) MALE PATIENT UNDERWENT A PROCEDURE THAT INCLUDED FOUR INTERVERTEBRAL SPACERS AND SIX LEVEL POSTERIOR FIXATION. THREE MONTHS AFTER SURGERY THE PATIENT WAS EXPERIENCING SOME PAIN (RADICULOPATHY) DOWN RIGHT SIDE. RADIOGRAPHIC IMAGES SHOWED A COMPONENT SEPARATION AT S1. THE SURGEON HAS ELECTED TO MONITOR THE PATIENT. NO REVISION SURGERY IS SCHEDULED AT THIS TIME.
Patient problems: Failure of Implant; Pain
MAUDE report 5493318 ↗MalfunctionJan 7, 2016Misconnection; Detachment of Device or Device Component; Misconnection; Detachment of Device or Device Component
ON (B)(6) 2015 A FEMALE PATIENTS POST-OPERATIVE RADIOLOGRAPHS SHOWED THE LEFT-SIDE ILIAC SCREW COMPONENTS HAD SEPARATED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. NO INJURY HAS BEEN REPORTED.
Patient problems: Failure of Implant
MAUDE report 5352213 ↗
Other APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY devices
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- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- Mariner RDX MX1-000040Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Mariner RDX MX1-000030Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430112Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430224Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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