MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION SHORELINE ACS; 6MM, LOCKING COVER

Model Number	85-2106
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A patient underwent spinal surgery on (b)(6) 2025 utilizing the seaspine/orthofix shoreline acs system.During the surgery, the shoreline acs locking cover broke.The plate was replaced with an alternate, however, the rep states a piece of the broken locking cover was left in-situ.The surgery was able to be completed and no patient injury or significant clinical delay was reported.
Additional Manufacturer Narrative
H3: device has been returned for investigation.Root cause is pending completion of the investigation.Review of labeling: possible adverse events bending, disassembly, or fracture of implant and components.
Additional Manufacturer Narrative
The 85-2106 6mm, locking cover was returned and evaluated.It was determined that the locking cover fractured towards the proximal end of the thread form.The wear pattern shows signs of the locking cover being delivered off-axis in relation to the waveform c interbody threads, which would be a key contributing factor to the failure mode.Review of labeling: possible adverse events.Bending, disassembly, or fracture of implant and components.

• Brand Name: SHORELINE ACS
• Common Device Name: 6MM, 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: danielle nelson-archer ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 23502504
• Report Number: 3012120772-2025-00056
• Device Sequence Number: 21080805
• Product Code: OVE
• UDI-Device Identifier: 10889981125073
• UDI-Public: 10889981125073
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K161081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 12/10/2025

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: 85-2106
• Device Catalogue Number: 85-2106
• Device Lot Number: MM20857472B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2023
• 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: Other
• Patient Sex: Unknown