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

Model Number	86-0010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned inserter was visually inspected to confirm the failure mode outlined in the description of the complaint.After reviewing the instrument, it was determined that the inner draw rod had fractured at a location approximately flush with the point on the outer sleeve where the draw rod is exposed.The reported failure 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.Possible adverse events 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
Seaspine/orthofix became aware on 05 feb 2026 that the tip of a shoreline acs inserter fractured intra-operatively when inserting the waveform c interbody.The fractured tip could not be retrieved from the interbody and was left in-situ.As a result, the locking cover was unable to be added to the construct.As the surgery was completed without the locking cover, orthofix/seaspine cannot guarantee the stability of the construct post-operatively.No patient injuries were reported.

• Brand Name: SHORELINE ACS
• Common Device Name: INSERTER
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA
• 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: 24533727
• Report Number: 3012120772-2026-00008
• Device Sequence Number: 9026996
• Product Code: OVE
• UDI-Device Identifier: 10889981126889
• UDI-Public: 10889981126889
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K161081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 03/06/2026

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: 86-0010
• Device Catalogue Number: 86-0010
• Device Lot Number: AL665062G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2022
• 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