MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION ADMIRAL; CERVICAL PLATE, 3 LEVEL, 51MM

Model Number	AP1-310051
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, a patient underwent cervical spinal surgery consisting of the admiral acp system.On (b)(6) 2025, it was reported that the admiral cervical plate failed to secure a mating screw, leading to a screw backout during the postoperative period.
Additional Manufacturer Narrative
The affected device remains implanted, with no revision surgery currently planned.Evaluation of the x-ray provided confirms the screw disengaged from the plate construct during the postoperative period.However, the root cause could not be determined, as the implant was not returned for investigation and the lot number was not provided for device history record review.Review of labeling: possible adverse events like other spinal system implants, the following adverse events are possible.This list is not exhaustive: 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.

• Brand Name: ADMIRAL
• Common Device Name: CERVICAL PLATE, 3 LEVEL, 51MM
• 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: audrey mudderman ; 5770 armada dr.; carlsbad, CA 92008 ; 7607278399
• MDR Report Key: 21548111
• Report Number: 3012120772-2025-00011
• Device Sequence Number: 14557891
• Product Code: KWQ
• UDI-Device Identifier: 10889981278304
• UDI-Public: 10889981278304
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K212139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/07/2025

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: AP1-310051
• Device Catalogue Number: AP1-310051
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 85-6107 INTERBODY, 16X14X7MM, 7 DEGREE, RT; 85-6108 INTERBODY, 16X14X8MM, 7 DEGREE, RT; AP1-704014 4.0MM VARIABLE ANGLE SCREW SELF-TAPPING
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Male