ACP 18009234Recalls & reported problems
Nuvasive, Inc. · ACP 1.9H Plate, 34mm 2-Level · Class 2 · Implant
All models of ACP (19)
Data updated Oct 16, 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 00195377008756), received between Mar 6, 2024 and Mar 6, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Abdominal Pain1
- Headache1
- Neck Pain1
- Rash1
- Swelling/ Edema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 6, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
ON (B)(6) 2023, A FEMALE PATIENT UNDERWENT AN ANTERIOR CERVICAL INTERBODY FUSION AT C5 TO C7 INCLUDING AN ACP PLATE AND SCREWS, 2 PEEK SPACERS FROM ANOTHER MANUFACTURER AS WELL AS AUTOGRAFT WITHOUT ISSUE, HOWEVER SEVERAL DAYS AFTER THE PROCEDURE THE PATIENT STARTED EXPERIENCING A REACTION. (BODY ACHES, PAIN AND SWELLING, HEAD ACHES, SICK TO STOMACH) POST REACTION ALLERGY TESTING IDENTIFIED A SEVER REACTION TO NICKLE. THE PATIENT IS WORKING WITH HER SURGEON AND ALLERGIST ON A PLAN BUT WANTS TO KNOW THE MATERIALS INVOLVED IN HER PRODUCTS.
Patient problems: Abdominal Pain; Headache; Neck Pain; Rash; Swelling/ Edema
MAUDE report 18847328 ↗
Other Appliance, fixation, spinal intervertebral body devices
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 6550017Medtronic Sofamor Danek, Inc. · Appliance, fixation, spinal intervertebral body131 reports
- EVEREST® Spinal System 2901-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- 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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