ACP 18008317Recalls & reported problems
Nuvasive, Inc. · ACP Screw, 3.5x17mm Self-Tap Variable · Class 2 · Implant
- 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 00887517065179), received between Aug 18, 2021 and Oct 18, 2022 — 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. How this data works · Data updated Oct 13, 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.
MalfunctionOct 18, 2022Migration; Migration
ON (B)(6) 2022 A SPINAL PROCEDURE WAS CONDUCTED. ON (B)(6) 2022 RADIOGRAPHS WERE TAKEN WHICH REVEALED A SCREW AND PLATE BACKED OUT. NO REVISION SURGERY IS PLANNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15627364 ↗MalfunctionMar 23, 2022Migration; Migration
ON (B)(6) 2021 A PATIENT UNDERWENT AN ANTERIOR CERVICAL PROCEDURE FROM C4 TO C7. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. ON (B)(6) 2022 IT WAS DISCOVERED DURING A POST-OP FOLLOW UP X-RAY THAT A CONSTRUCT SCREW HAD BACKED OUT AT THE C7 LEVEL. THE PATIENT WAS EXPERIENCING NO ADVERSE EFFECTS AS A CONSEQUENCE OF THE ISSUE AND NO REVISION IS PLANNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13861574 ↗MalfunctionJan 4, 2022Migration; Migration
ON (B)(6) 2021, AN ANTERIOR CERVICAL DISCECTOMY AND FUSION WAS PERFORMED AT C3/6. ON (B)(6) 2021, IT WAS DISCOVERED THAT A SCREW BACKED OUT. THERE IS NO PATIENT INJURY REPORTED AND NO REVISION SURGERY IS PLANNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13153847 ↗MalfunctionAug 18, 2021Migration; Migration
ON (B)(6) 2021 A SPINAL PROCEDURE TOOK PLACE. ON (B)(6) 2021 IT WAS DISCOVERED DURING A FOLLOW UP THAT A SCREW HAD BACKED OUT. THERE WAS ZERO SUBSIDENCE. NO PATIENT INJURY REPORTED. NO REVISION SURGERY SCHEDULED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12338050 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.