MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION ADMIRAL; SCREW

Model Number	AP1-704016
Medical Device Problem Codes	Fracture (1260); Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected screw had fractured approximately in half; only the top portion was returned.Multiple attempts were made to obtain further information; no response was received.It is unknown if the remainder of the screw was left implanted.The outcome of the investigation is still pending.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
On 03 mar 2025, seaspine/orthofix was made aware of a screw backout on an admiral cervical plate construct.The provided x-ray corroborates the report.Removal surgery was performed on (b)(6) 2025.
Additional Manufacturer Narrative
Update to h3: device evaluated by manufacturer changed to "yes".Update to adverse event problem codes.Investigation: physical evaluation of the screw observed distal tip sheared off about halfway down the screw shank.However, it is unclear if that was a result of the removal workflow or if that fracture occurred in-situ.Additionally, the screw was returned with an ap1-210034 cervical plate, 2 level, 34mm.Upon investigation it was confirmed that the locking cover on the inferior right side of the plate was broken.This broken locking cover corresponded with the screw that had backed out on the x-ray image provided.Report 3012120772-2025-00033 was created to document the potential ap1-210034 cervical plate, 2 level, 34mm post-operative fracture.Root cause: 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.

• Brand Name: ADMIRAL
• Common Device Name: SCREW
• 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: 21720462
• Report Number: 3012120772-2025-00010
• Device Sequence Number: 3862800
• Product Code: KWQ
• UDI-Device Identifier: 10889981278847
• UDI-Public: 10889981278847
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• 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: AP1-704016
• Device Catalogue Number: AP1-704016
• Device Lot Number: DM1122352B
• 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: 03/03/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2022
• 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: AP1-210034 CERVICAL PLATE, 2 LEVEL, 34MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown