ACP 18006120Recalls & reported problems
Nuvasive, Inc. · ACP 1.6V Plate, 20mm 1-Level · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00195377009975), received between Jan 7, 2022 and Oct 18, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 18, 2022Fracture; Fracture
WE HAD AN ACP PLATE REMOVAL TODAY DUE TO SCREW BACK OUT AND NON-UNION. ACP PLATE AND MODULUS IMPLANTS WERE ORIGINALLY IMPLANTED ON (B)(6) 2021 AND THE PATIENT WAS BROUGHT BACK ON (B)(6) 2022 DUE TO SCREWS NOTICEABLY BACKING OUT ON IMAGING. THE CAM LOCK WAS FRACTURED- THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15621527 ↗MalfunctionJan 7, 2022Migration; Migration
A LIST OF NEW INFORMATION PROVIDED IN SECTION H10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13198292 ↗
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- 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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