MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION ADMIRAL; 4.0MM VARIABLE ANGLE SCREW, SELF-TAPPING, 14MM

Model Number	AP1-704014
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Two screws were returned; investigation is pending.
Event or Problem Description
On 05 may 2025, seaspine/orthofix was made aware of a revision surgery due to a screw that backed out of an admiral cervical plate construct.The provided x-ray corroborates the report.Two screws and the plate's inferior locking cover were removed.The surgeon chose to leave the plate and remaining screws in-situ.No patient injury was reported.This report is for 1 of 2 ap1-704014 4.0mm variable angle screws, self-tapping, 14mm.The ap1-310045 cervical plate, 3 level, 45mm was reported on 3012120772-2025-00034.
Additional Manufacturer Narrative
Update to h3: changed to "yes." update to adverse event problem codes.Physical evaluation of the screw noted no major damage.Upon review of the index and revision surgery case information, it was observed that during both surgeries, 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.

• Brand Name: ADMIRAL
• Common Device Name: 4.0MM VARIABLE ANGLE SCREW, SELF-TAPPING, 14MM
• 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: 22127702
• Report Number: 3012120772-2025-00035
• Device Sequence Number: 15276929
• Product Code: KWQ
• UDI-Device Identifier: 10889981278823
• UDI-Public: 10889981278823
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K212139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted 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): 07/08/2025

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: AP1-704014
• Device Catalogue Number: AP1-704014
• Device Lot Number: BR39401B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown