ACP 18008115Recalls & reported problems
Nuvasive, Inc. · ACP Screw, 3.5x15mm Self-Drill Variable · Class 2 · Implant
All models of ACP (19)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00195377009395), received between Jun 18, 2021 and Aug 20, 2021 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Migration” (4 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
- Migration4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 20, 2021Migration; Migration
ON (B)(6) 2021 A PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION AT C3/4 AND C7/T1. IT WAS IDENTIFIED ON (B)(6) 2021 THAT BOTH PLATES HAVE MIGRATED AND HAVE SCREWS BACKING OUT. THERE IS NO REVISION SURGERY PLANNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12351248 ↗MalfunctionAug 20, 2021Migration; Migration
ON (B)(6) 2021 A PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION AT C3/4 AND C7/T1. IT WAS IDENTIFIED ON (B)(6) 2021 THAT BOTH PLATES HAVE MIGRATED AND HAVE SCREWS BACKING OUT. THERE IS NO REVISION SURGERY PLANNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12351245 ↗MalfunctionAug 12, 2021Migration; Migration
ON (B)(6) 2021 A FEMALE PATIENT UNDERWENT AN ANTERIOR CERVICAL DISC FUSION PROCEDURE ON C6-C7. ON (B)(6) 2021 POST OPERATIVE FILMS WERE TAKEN SHOWING THE INFERIOR ASPECT OF THE PLATE TO BE ABOUT 1MM PROUD. THE SURGEON NOTES STATED THE CAGE IN GOOD POSITION AND THERE IS NO EVIDENCE OF SCREW MIGRATION OR FRACTURE. ON A FOLLOW UP APPOINTMENT ON (B)(6) 2021 A COMPARISON X-RAY TAKEN AND WHERE THE SURGEON BELIEVED THE CONSTRUCT TO BE STABLE DEMONSTRATING POSTSURGICAL CHANGES WITHOUT APPARENT COMPLICATIONS. THE DEVICE REMAINS IN SITU AND PATIENT STATUS WILL CONTINUE TO BE MONITORED. NO REVISION IS PLANNED AT THIS TIME
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12314173 ↗MalfunctionJun 18, 2021Migration; Migration
A FEMALE PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE FROM THE C4-C6 LEVELS. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. ON (B)(6) IT WAS REPORTED THAT A CERVICAL SCREW BACK OUT HAD OCCURRED AT THE C4 LEVEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12026515 ↗
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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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