MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION SHORELINE ACS; 6-7MM, NO PROFILE LOCKING COVER

Model Number	85-2006
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of post-operative x-rays confirms the anterior cervical construct was implanted across two levels using the waveform c interbody and shoreline acs no-profile plate systems.Imaging indicates the shoreline acs no-profile locking cover appears disengaged or not fully seated in one of the waveform c interbody devices.All other components, including screws and interbody cages, appear intact, with no evidence of fracture, migration, or loosening.No details regarding revision surgery have been provided.The product remains implanted and was not returned for evaluation.Additionally, no lot number was provided; therefore a review of the device history record could not be conducted.The cause of the locking cover migration is undetermined.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
A patient underwent anterior cervical discectomy fusion (acdf) spine surgery on (b)(6) 2025 utilizing seaspine/orthofix's waveform c and shoreline acs systems.On (b)(6) 2025, seaspine/orthofix was notified that the shoreline acs no-profile locking cover had prematurely disengaged from the waveform c no-profile interbody construct.

• Brand Name: SHORELINE ACS
• Common Device Name: 6-7MM, NO PROFILE LOCKING COVER
• 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
• MDR Report Key: 22507315
• Report Number: 3012120772-2025-00042
• Device Sequence Number: 8736678
• Product Code: OVE
• UDI-Device Identifier: 10889981125042
• UDI-Public: 10889981125042
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161081
• 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): 07/15/2025

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: 85-2006
• Device Catalogue Number: 85-2006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 07/15/2025
• 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: 85-3016 SHORELINE -3.5MM VARIABLE SCREW.; 85-3114 SHORELINE -3.5MM FIXED ANGLE SCREW.; 85-3116 SHORELINE -3.5MM FIXED ANGLE SCREW.; AC4-164067 NT -WAVEFORM# C -NO PROFILE SPACER.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown