Segmental Plating System 338-1-23518Recalls & reported problems
Alphatec Spine, Inc. · SPS VA Self-Drill Screw, 3.5 x 18 mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00190376536194), received between May 29, 2025 and May 29, 2025 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Fracture1
Patient problems
- Failure of Implant1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 29, 2025Fracture; Fracture
A PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION AT LEVELS C4-C7. APPROXIMATELY FOUR AND A HALF MONTHS POSTOPERATIVELY, RADIOGRAPHIC IMAGING REVEALED A BROKEN SCREW AT THE C5 LEVEL. THE PATIENT IS SYMPTOMATIC, REPORTING DISCOMFORT AT THE LEVEL ABOVE THE BROKEN SCREW. REVISION SURGERY IS PLANNED.
Patient problems: Failure of Implant; Pain
MAUDE report 22108014 ↗
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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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