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

Model Number	AP2-100506
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the reporter, the two ap2-100506 temporary fixation pins were discarded.As a result, the product was not available for evaluation.Additionally, no lot information was provided.No definitive root cause could be established.Review of labeling: possible adverse events bending, disassembly, or fracture of implant and components.Intraoperative fissure, fracture, or perforation of the spine.
Event or Problem Description
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.

• Brand Name: ADMIRAL
• 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: 24059565
• Report Number: 3012120772-2025-00074
• Device Sequence Number: 9466403
• Product Code: LXH
• UDI-Device Identifier: 10889981277109
• UDI-Public: 10889981277109
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AP2-100506
• Device Catalogue Number: AP2-100506
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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