ACP 18008215Recalls & reported problems
Nuvasive, Inc. · ACP Screw, 3.5x15mm Self-Drill Fixed · Class 2 · Implant
All models of ACP (19)
Data updated Oct 16, 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 00195377009289), received between Jun 22, 2021 and Nov 11, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Migration” (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
- Migration2
Patient problems
- Dysphagia/ Odynophagia2
- Neck Stiffness2
- Numbness2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 11, 2021Migration; Migration
ADDITIONAL INFORMATION RECEIVED REQUIRED ADDITIONAL INVESTIGATION PROVIDED ON H10.
Patient problems: Dysphagia/ Odynophagia; Neck Stiffness; Numbness
MAUDE report 12799682 ↗MalfunctionJun 22, 2021Migration; Migration
ADDITIONAL INFORMATION RECEIVED REQUIRED ADDITIONAL INVESTIGATION PROVIDED ON H10.
Patient problems: Dysphagia/ Odynophagia; Neck Stiffness; Numbness
MAUDE report 12042197 ↗
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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