MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION ADMIRAL; CERVICAL PLATE, 2 LEVEL, 34MM

Model Number	AP1-210034
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon review of the index surgery, it was observed that the surgeon used a shoreline system drill to complete the screw hole preparation step for the related admiral plate.This is off-label use of the shoreline drill as the design is intended for the standard 3.5mm screws in the shoreline system, not the standard 4.0mm screws in the admiral system.The reduced drill flute diameter means that the admiral screws must displace about 6% more bone during screw insertion, which adds shear stress to the screw while creating the plate construct.This can prevent the screw from reaching its intended full seat in the plate pocket and can attribute to more pressure on the screws in the construct post-operatively.Review of labeling: possible adverse events bending, disassembly, or fracture of implant and components loosening of spinal fixation implants may occur due to inadequate initial fixation, latent infection, and/or premature loading, possibly resulting in bone erosion, migration, or pain.
Event or Problem Description
Upon investigation of the screw back-out previously filed on 3012120772-2025-00010, it was confirmed that the locking cover on the inferior right side of the returned cervical plate was broken.This broken locking cover corresponded with the screw that had backed out on the x-ray image provided.It is unclear if that was a result of the removal workflow or if that fracture occurred in-situ.

• Brand Name: ADMIRAL
• Common Device Name: CERVICAL PLATE, 2 LEVEL, 34MM
• 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: amanda fonseca ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165655
• MDR Report Key: 22074374
• Report Number: 3012120772-2025-00033
• Device Sequence Number: 18482372
• Product Code: KWQ
• UDI-Device Identifier: 10889981278144
• UDI-Public: 10889981278144
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K212139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted 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): 05/22/2025

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: AP1-210034
• Device Catalogue Number: AP1-210034
• Device Lot Number: AR91943A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AP1-704016 4.0MM VARIABLE ANGLE SCREW
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown