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

Model Number	86-0011
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Only the 86-0011-20 inner draw rod was returned for evaluation.The outer sleeve component was not returned, and lot information was unavailable.Evaluation of the returned device confirmed fracture of the inserter draw rod threaded region.The observed condition is consistent with a known failure mode.Investigation determined the failure is multifactorial and associated with the strength of the draw rod material, stress concentrations within the thread form at the fracture location, and use conditions that may increase tensile loading on the threaded region of the inserter.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.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 pain, discomfort, or abnormal sensations due to the presence of the device.
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 threaded portion of the inserter fractured and remained within an implanted orthofix waveform c interbody device.The procedure was delayed approximately 5-7 minutes.The procedure was completed with the fractured threaded portion remaining within the waveform c interbody device and a non-orthofix 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 WITH STOP
• 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: 25375208
• Report Number: 3012120772-2026-00029
• Device Sequence Number: 16104561
• Product Code: OVE
• UDI-Device Identifier: 10889981137472
• UDI-Public: 10889981137472
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K233414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2026

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: 86-0011
• Device Catalogue Number: 86-0011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown