Admiral AP1-310045Recalls & reported problems
Seaspine Orthopedics Corporation · Cervical Plate, 3 Level, 45mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10889981278281), received between Jun 2, 2025 and Mar 3, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Separation Problem1
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 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 4.0 MM 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 AP1-310045 CERVICAL PLATE, 3 LEVEL, 45MM. SEE 3012120772-2026-00005 REPORT FOR THE AP1-714016 4.0 MM VARIABLE ANGLE SCREW, SELF-DRILLING, 16 MM.
Patient problems: Insufficient Information
MAUDE report 24497564 ↗InjuryJun 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ON 05 MAY 2025, SEASPINE/ORTHOFIX WAS MADE AWARE OF A REVISION SURGERY DUE TO A SCREW THAT BACKED OUT OF AN ADMIRAL CERVICAL PLATE CONSTRUCT. THE PROVIDED X-RAY CORROBORATES THE REPORT. TWO SCREWS AND THE PLATE'S INFERIOR LOCKING COVER WERE REMOVED. THE SURGEON CHOSE TO LEAVE THE PLATE AND REMAINING SCREWS IN-SITU. NO PATIENT INJURY WAS REPORTED. THIS REPORT IS FOR THE AP1-310045 CERVICAL PLATE, 3 LEVEL, 45MM. THE AP1-704014 4.0MM VARIABLE ANGLE SCREWS, SELF-TAPPING, 14MM WERE REPORTED ON 3012120772-2025-00035 AND 3012120772-2025-00036.
Patient problems: Insufficient Information
MAUDE report 22127492 ↗
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- Elegance® Anterior Cervical Plate 53430114Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
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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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