ACP 18008315Recalls & reported problems
Nuvasive, Inc. · ACP Screw, 3.5x15mm Self-Tap Variable · Class 2 · Implant
Data updated Oct 13, 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 00887517065155), received between Jul 14, 2022 and Aug 1, 2023 — 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fracture1
- Migration1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 1, 2023Migration; Migration
THIS COMPLAINT WAS DISCOVERED DURING REVIEW OF OLDER COMPLAINTS THAT WAS MISSED AS IT WAS REPORTED IN AMONGST ANOTHER REPORTED EVENT: ON A (B)(6) 2021 A PATIENT UNDERWENT AN ANTERIOR CERVICAL PROCEDURE FROM C4 TO C6. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. ON A (B)(6) 2022 DATE IT WAS DISCOVERED DURING A POST-OP FOLLOW UP X-RAY THAT A PLATE SCREW HAD BACKED OUT AT THE C6 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 17437793 ↗MalfunctionJul 14, 2022Fracture; Fracture
ON (B)(6)2022, THE HEAD OF AN ACP SCREW SHEERED WHILE INSERTING. THE SCREW SHANK WAS LEFT IN PLACE. NO PATIENT IMPACT WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: Foreign Body In Patient
MAUDE report 15015749 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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