MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION ADMIRAL ACP SYSTEM; TEMPORARY FIXATION PIN,

Model Number	AP2-100506
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ap2-100506 temporary fixation pin was returned for analysis and is currently under evaluation.Review of qf-10-01 admiral acp system ifu: possible adverse events: bending, disassembly, or fracture of components.
Event or Problem Description
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.
Additional Manufacturer Narrative
Inspection of the returned fixation pin showed it fractured about 2.5 mm from the screw head.Microscopic examination revealed material compression on one side of the fracture surface, indicating the pin failed under significant bending loads.This suggests the pin likely broke during screw deployment rather than during initial placement or plate positioning.The pin was reportedly placed in an inferior screw hole, and inserting superior screws first could have increased bending stress on the inferior pin.There was no indication the surgeon had difficulty maintaining plate position, further supporting that the fracture occurred after one or more screws were already deployed.Because the break was only noticed at the end of the procedure, multiple screws may have been placed before the fracture occurred.An additional contributing factor may have been hyper-angulated insertion of the fixation pin.While using the screw hole can improve plate stabilization, it also increases trajectory variability, and excessive angulation could have amplified bending moments on the pin, leading to fracture.Review of qf-10-01 admiral acp system ifu: possible adverse events, bending, disassembly, or fracture of components.

• Brand Name: ADMIRAL ACP SYSTEM
• Common Device Name: TEMPORARY FIXATION PIN,
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad, CA 92008
• Manufacturer (Section G): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer Contact: robin quiusky ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 23583989
• Report Number: 3012120772-2025-00061
• Device Sequence Number: 21215657
• Product Code: LXH
• UDI-Device Identifier: 10889981277109
• UDI-Public: 10889981277109
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AP2-100506
• Device Catalogue Number: AP2-100506
• Device Lot Number: TE180389C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown