Admiral AP2-100506Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10889981277109), received between Jul 21, 2023 and Jan 13, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Material Fragmentation

  ON (B)(6) 2025, A PATIENT UNDERWENT SPINAL SURGERY UTILIZING SEASPINE'S ADMIRAL ACP SYSTEM. IT WAS REPORTED THAT TWO TEMPORARY FIXATION PINS (AP2-100506) FRACTURED AND THE TIPS WERE LEFT INSIDE THE PATIENT'S BONE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24059565 ↗
• MalfunctionNov 18, 2025Fracture; Fracture

  ON (B)(6) 2025, A PATIENT UNDERWENT SPINAL SURGERY CONSISTING OF SEASPINE'S ADMIRAL ACP SYSTEM. DURING THE PROCEDURE A TEMPORARY FIXATION PIN (AP2100506) WAS PLACED INTO THE LOWER SCREW HOLE OF THE PLATE. SCREWS WERE PLACED INTO ALL OTHER SCREW HOLES. UPON REMOVAL OF THE TEMPORARY FIXATION PIN IT WAS OBSERVED THAT A SIGNIFICANT PORTION OF THE PIN HAD BROKEN AND REMAINED IN BONE. THE REPORTER NOTED THAT THE BROKEN FRAGMENT WAS NOT RETRIEVED FROM THE SURGICAL SITE. A NEW TRAJECTORY WAS DRILLED AND A SHORTENED SCREW WAS PLACED. THE REPORTER NOTED THAT NO OBSERVABLE INJURY RESULTED FROM THE BROKEN FIXATION PIN, HOWEVER THE BROKEN FRAGMENT REMAINS IN THE BONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23583989 ↗
• MalfunctionMar 7, 2025Material Fragmentation; Material Fragmentation

  CUSTOMER REPORTS THAT DURING A SURGERY THAT TOOK PLACE ON (B)(6) 2025, AN ADMIRAL TEMPORARY FIXATION PIN BROKE WITH THE DISTAL PORTION OF THE PIN REMAINING IN THE BONE. THERE WAS NO WAY TO RETRIEVE THE PIECE THAT REMAINED IN THE BONE; HOWEVER, THE SURGEON DID NOT FEEL THERE WAS ANY RISK OF THAT PORTION BACKING OUT OF THE BONE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN SURGERY AND NO PATIENT INJURY REPORTED. THE ADMIRAL TEMPORARY FIXATION PIN WAS NOT SAVED BY THE CUSTOMER DUE TO THE SIZE AND SHARPNESS, THEREFORE, THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. ADDITIONALLY, THE CUSTOMER STATES THE LOT NUMBER WAS NOT LEGIBLE AS THE LASER MARKING WAS NO LONGER DARK AND WAS INCREDIBLY SMALL.

  Patient problems: Foreign Body In Patient

  MAUDE report 21554470 ↗
• MalfunctionJul 21, 2023Fracture; Fracture

  ON (B)(6) 2023, A PATIENT UNDERWENT SPINAL SURGERY CONSISTING OF SEASPINE'S ADMIRAL ACP SYSTEM. DURING THE PROCEDURE, AN AP2-100506 TEMPORARY FIXATION PIN WAS INSERTED THROUGH A SCREW HOLE; THE TEMPORARY FIXATION PIN WAS THEN REMOVED WITHOUT BEING AWARE THAT THE PIN HAD FRACTURED AND A FRAGMENT WAS LEFT IN THE SURGICAL SITE. THE SURGEON CONTINUED THROUGH THE PROCEDURE BY INSERTING AN AP2-100314 ADMIRAL ACP DRILL, 14MM INTO THE SAME SCREW HOLE. THE ACP DRILL MADE CONTACT WITH THE TEMPORARY FIXATION PIN AND CREATED ENOUGH FRICTION TO CAUSE IT TO FRACTURE AS WELL. FRAGMENTS OF BOTH THE AP2-100506 TEMPORARY FIXATION PIN AND THE AP2-100314 ACP DRILL REMAIN IN-SITU. NO REPORTS OF TISSUE DAMAGE OR PATIENT INJURY WAS REPORTED AND THERE ARE NO PLANS FOR REVISION OR REMOVAL AT THIS TIME. SEASPINE WAS MADE AWARE OF THIS INCIDENT ON (B)(6) 2023. REPORT # AP2-100506 TEMPORARY FIXATION PIN. REPORT #3012120772-2023-00014 AP2-100314 ACP DRILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17372603 ↗