MAUDE Adverse Event Report: SeaSpine Orthopedics Corporation Shoreline ACS; 7mm, Locking Cover

Model Number	85-2107
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Orthofix was made aware on 12 aug 2026 that a patient underwent spinal surgery consisting of the shoreline acs system.The index surgery occurred on (b)(6) 2026.It was reported that an 85-2107 7mm, locking cover fractured into the interbody intra-operatively and the threaded portion was left in the interbody.The fracture occurred when the surgeon tried to advance the 85-2107 7mm, locking cover using the locking handle.According to the reporter, the 85-2107 7mm, locking cover did not advance and was not seated properly.Since the interbody was already fixated at c6-7 with the screws, the surgeon elected to leave the construct in place and not remove the fractured threaded portion of the locking cover.No patient injuries or additional medical intervention were reported.Per the reporter, the patient is recovering well.
Additional Manufacturer Narrative
The affected device was not returned for evaluation.The lot number was not provided; therefore, a device history record review could not be performed.According to the reporter, the 85-2107 7mm, locking cover was not available for evaluation because it was discarded.A photo was provided which appears to confirm the reported failure mode that the threaded portion of the locking cover fractured.Due to the absence of the returned device the specific root cause cannot be conclusively determined.No patient injury, revision surgery, or additional medical intervention has been reported.Review of labeling: 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.

• Brand Name: Shoreline ACS
• Common Device Name: 7mm, 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: robin quiusky ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 50693454
• Report Number: 3012120772-2026-00044
• Device Sequence Number: 5891811
• Product Code: OVE
• UDI-Device Identifier: 10889981125080
• UDI-Public: 10889981125080
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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: 85-2107
• Device Catalogue Number: 85-2107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AC4-285077 Interbody, 18x15x7mm, 7 Degree, 3D.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown