Admiral AP1-714018Recalls & reported problems
Seaspine Orthopedics Corporation · 4.0mm Variable Angle Screw, Self-Drilling, 18mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10889981279103), received between Jan 30, 2025 and Mar 19, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Separation Problem” (2 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.
Reports received per month
Most reported problems
Device problems
- Separation Problem2
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Insufficient Information3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 19, 2026Separation Problem
A PATIENT UNDERWENT A 3 LEVEL ACDF SPINAL SURGERY ON (B)(6) 2024 CONSISTING OF THE SEASPINE/ORTHOFIX ADMIRAL ACP SYSTEM. SEASPINE/ORTHOFIX WAS MADE AWARE ON 20 FEB 2026 THAT SCREWS BACKED OUT APPROXIMATELY 12 MONTHS POST-OPERATIVELY. THE X-RAY PROVIDED APPEARS TO SHOW THAT ONE OF THE TOP SCREWS (SUPERIOR MOST) HAS BACKED OUT. ADDITIONALLY, ONE OF THE INFERIORS-MOST SCREWS (CAUDAL SCREWS) APPEARS TO BE SLIGHTLY MORE PROMINENT COMPARED TO THE OTHERS. THE PART NUMBERS THAT WERE REPORTED WERE AP1-714018 4.0MM VARIABLE ANGLE SCREW AND A AP1-310054 CERVICAL PLATE, 3 LEVEL, 54MM. 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 AP1-714018 4.0MM VARIABLE ANGLE SCREW. SEE 3012120772-2026-00011 REPORT FOR THE AP1-310054 CERVICAL PLATE, 3 LEVEL, 54MM.
Patient problems: Insufficient Information
MAUDE report 24644373 ↗MalfunctionMar 3, 2026Separation Problem
A PATIENT UNDERWENT A 3 LEVEL ACDF SPINAL SURGERY ON (B)(6) 2025 CONSISTING OF THE SEASPINE/ORTHOFIX ADMIRAL ACP SYSTEM. SEASPINE/ORTHOFIX WAS MADE AWARE ON (B)(6) 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 AP1-714018 4.0MM VARIABLE ANGLE SCREW AND A AP1-310051 CERVICAL PLATE, 3 LEVEL, 51MM. THE REPORTER NOTED THAT THE LOCKING COVERS OF THE AP1-310051 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 AP1-714018 4.0 MM VARIABLE ANGLE SCREW. SEE 3012120772-2026-00006 REPORT FOR THE AP1-310051 CERVICAL PLATE, 3 LEVEL, 51 MM.
Patient problems: Insufficient Information
MAUDE report 24499646 ↗MalfunctionJan 30, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
CUSTOMER REPORTS AN X-RAY TAKEN ALMOST A YEAR AFTER SURGERY SHOWS AN ADMIRAL VARIABLE ANGLE SCREW HAS BACKED OUT OF WHAT APPEARS TO BE A LOCKED PLATE. ALTHOUGH THREE FOLLOW-UP ATTEMPTS WERE PERFORMED, CUSTOMER WAS UNRESPONSIVE. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS EVENT. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION.
Patient problems: Insufficient Information
MAUDE report 21277647 ↗
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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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