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

Model Number	86-0013
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned for evaluation.Additionally, no lot information was provided; therefore, a device history record review could not be performed.Without the returned device, a definitive root cause could not be determined.No information was provided indicating patient injury as a result of the reported event.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.
Event or Problem Description
On (b)(6) 2026, orthofix became aware of a report involving a shoreline inserter that fractured during a spinal fusion procedure while in contact with the patient.It was reported that the inserter fractured and a fragment remained implanted.The procedure was delayed approximately 10 minutes.The procedure was completed with the fragment remaining within the implant and an admiral plate implanted over the interbody.No patient injury, death, or additional medical or surgical intervention was reported.

• Brand Name: SHORELINE ACS
• Common Device Name: INSERTER, SPACER
• 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: 25510737
• Report Number: 3012120772-2026-00031
• Device Sequence Number: 10552784
• Product Code: OVE
• UDI-Device Identifier: 10889981164546
• UDI-Public: 10889981164546
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K183083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/15/2026

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: 86-0013
• Device Catalogue Number: 86-0013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown