Admiral AP1-714016Recalls & reported problems
Seaspine Orthopedics Corporation · 4.0mm Variable Angle Screw, Self-Drilling, 16mm · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889981279080), received between Mar 3, 2026 and Mar 3, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Separation Problem” (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
- Separation Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 3, 2026Separation Problem
A PATIENT UNDERWENT A 3 LEVEL ACDF SPINAL SURGERY ON (B)(6) 2023 CONSISTING OF THE SEASPINE/ORTHOFIX ADMIRAL ACP SYSTEM. SEASPINE/ORTHOFIX WAS MADE AWARE ON 06 FEB 2026 THAT ONE OF THE INFERIOR-MOST SCREWS (CAUDAL SCREWS) BACKED OUT, APPROXIMATELY 6 MONTHS POST-OPERATIVELY. THE PART NUMBERS THAT WERE REPORTED WERE A AP1-714016 4.0MM VARIABLE ANGLE SCREW AND A AP1-310045 CERVICAL PLATE 3 LEVEL. THE REPORTER NOTED THAT THE LOCKING COVERS OF THE AP1-310045 CERVICAL PLATE APPEARED TO HAVE BEEN APPROPRIATELY ENGAGED AT THE COMPLETION OF THE INDEX SURGERY. NO PATIENT INJURY WAS REPORTED. CURRENTLY, THE PATIENT IS BEING MONITORED BY THE SURGEON AND NO REVISION SURGERY IS PLANNED. THIS REPORT IS BEING FILED FOR THE AP1-714016 4.0MM VARIABLE ANGLE SCREW, SELF-DRILLING, 16MM. SEE 3012120772-2026-00004 REPORT FOR THE AP1-310045 CERVICAL PLATE, 3 LEVEL, 45MM.
Patient problems: Insufficient Information
MAUDE report 24497563 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.