MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION SHORELINE ACS; INSERTER

Model Number	86-0010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent spinal surgery consisting of shoreline acs and waveform c systems.The tip of the shoreline inserter snapped at the threads while implanting the waveform c interbody.The broken tip was unable to be removed from the implant and the construct was left in-situ without a locking cover.The event did not lead to a clinically relevant increase in the duration of the surgical procedure and the surgery was completed successfully.The reporter confirms there was no patient injury, and the issue did not require additional medical or surgical treatment.
Additional Manufacturer Narrative
H3: the instrument has been returned, but the outcome of the investigation is still pending.Review of labeling: intraoperative warnings breakage, slippage, or misuse of instruments or implant components may cause injury to the patient or operative personnel.
Additional Manufacturer Narrative
Update to h3: changed to "yes" update to adverse event problem codes investigation conclusion: the returned inserter draw rod was visually inspected to confirm the failure mode outlined in the description of the complaint.After reviewing the rod component, it was confirmed that the threaded tip was fractured near the proximal thread runout point.Root cause: the reported complaint may be due to misuse, surgical technique, or excessive torsional force.These devices are part of loaner sets that are subject to handling and repeat use after distribution.Wear and damage can occur over time.Exact root cause unable to be determined.

• Brand Name: SHORELINE ACS
• Common Device Name: INSERTER
• 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: 22031462
• Report Number: 3012120772-2025-00032
• Device Sequence Number: 8160922
• Product Code: OVE
• UDI-Device Identifier: 10889981126889
• UDI-Public: 10889981126889
• 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
• 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): 06/03/2025

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: 86-0010
• Device Catalogue Number: 86-0010
• Device Lot Number: AL675526H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: WAVEFORM C INTERBODY, PN AC4-264081, LOT CV0913E.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown