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

Model Number	85-2006
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the postoperative x-rays confirms that the locking cover does not appear to be seated flush against the spacer as intended.Imaging from the index surgery was requested to assess initial placement and locking mechanism engagement; however, these images were not made available for review.As a result, it could not be confirmed whether the locking cover was fully engaged at the time of the initial procedure.Multiple good faith efforts were made to obtain follow-up information regarding the patient's condition and potential revision; however, no additional clinical details were received.The distributor reported no patient injury.Surgical intervention could not be confirmed.Root cause undetermined.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.
Event or Problem Description
A patient underwent anterior cervical discectomy fusion (acdf) spinal surgery on (b)(6) 2025.On (b)(6) 2025, it was observed during routine postoperative follow up that the no profile locking cover was not properly seated in the no profile spacer.
Additional Manufacturer Narrative
Review of the postoperative x-rays confirms that the locking cover has separated from the interbody/spacer construct.Imaging from the index surgery was requested to assess initial placement and locking mechanism engagement; however, these images were not made available for review.As a result, it could not be confirmed whether the locking cover was fully engaged at the time of the initial procedure.The distributor reported no patient injury and revision surgery is pending.The root cause cannot be determined at this time.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.
Event or Problem Description
A patient underwent anterior cervical discectomy fusion (acdf) spinal surgery on (b)(6) 2025.On (b)(6) 2025, it was observed during routine postoperative follow up that the no profile locking cover separated from the no profile spacer.

• 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: 22168864
• Report Number: 3012120772-2025-00038
• Device Sequence Number: 12717214
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 05/16/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 07/31/2025
• 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: 85-3216 3.5 MM VARIABLE SCREW, SELF DRILLING; 85-3316 3.5 MM FIXED ANGLE SCREW, SELF DRILLING; AC4-164077 WAVEFORM C, NO PROFILE SPACER 16 X 14 X 7 MM
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown