ACP 18006236Recalls & reported problems
Nuvasive, Inc. · ACP 1.6V Plate, 36mm 2-Level · Class 2 · Implant
- 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 00195377009784), received between Mar 24, 2022 and Jan 10, 2024 — classified as 2 malfunctions.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Migration2
- Detachment of Device or Device Component1
- Migration or Expulsion of Device1
- Noise, Audible1
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.
MalfunctionJan 10, 2024Migration or Expulsion of Device; Detachment of Device or Device Component; Noise, Audible; Migration; Migration or Expulsion of Device; Detachment of Device or Device Component; Noise, Audible; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TWO (2) LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) PROCEDURE AT C3-C5. SUBSEQUENTLY, ON AN UNKNOWN DATE APPROXIMATELY SEVEN (7) MONTHS POST-OP, THE PATIENT COMPLAINED OF CLICKING IN THEIR NECK. RADIOGRAPH IMAGES WERE OBTAINED AND IT WAS DISCOVERED THAT THE LOCKING MECHANISM ON THE PLATE APPEARED TO HAVE FAILED AND AT LEAST ONE SCREW HAD BACKED OUT AT C5 AND POTENTIALLY ONE OR BOTH SCREWS AT C3. THE SURGEON WANTS TO REVISE THE PATIENT; HOWEVER, NO REVISION PROCEDURE HAS BEEN SCHEDULED AS THE SURGEON STATED THE PATIENT HAS NOT BEEN COMPLIANT. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18484758 ↗MalfunctionMar 24, 2022Migration; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL THREE (3) LEVEL ANTERIOR CERVICAL PLATE FIXATION PROCEDURE. SUBSEQUENTLY, A POST-OPERATIVE EVALUATION PERFORMED SIXTEEN (16) MONTHS LATER IDENTIFIED BOTH SCREWS AT THE BOTTOM LEVEL APPEARED TO BE BACKING OUT. THERE IS NO INTENT TO REVISE THE CONSTRUCT AT THIS TIME. NO FURTHER PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13896312 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.