MAUDE Adverse Event Report: SPINAL ELEMENTS, INC SAPPHIRE; ANTERIOR CERVICAL PLATE SYSTEM

Catalog Number	27140-016
Medical Device Problem Codes	Fracture (1260); Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Images received depict a three level anterior plate with one inferior screw that is fractured, confirming the event.Dhr review cannot be completed at this time as lot number was not provided and product cannot be evaluated as it remains in the patient.Unknown factors include: patient activity at the time or prior to the event, patient bone quality, the degree of spinal instability, the degree of post lateral pseudarthrosis (though only four months post-op) or patient compliance with post-operative care instructions or if the patient sustained a fall/impact of any sort (no trauma was reported.) these factors dictate the longevity of the implant.Root cause cannot be determined.
Event or Problem Description
On (b)(6) 2025, patient underwent a three level acdf procedure.During routine 4 month follow up it was reported that a bone screw had fractured.Patient is asymptomatic currently, with no plan for revision surgery at this time.

• Brand Name: SAPPHIRE
• Common Device Name: ANTERIOR CERVICAL PLATE SYSTEM
• Manufacturer (Section D): SPINAL ELEMENTS, INC; 3115 melrose drive, suite 200; carlsbad CA 92010
• Manufacturer Contact: peter perhach ; 15 melrose drive, suite 200; carlsbad, CA 92010 ; 7606071830
• MDR Report Key: 22287449
• Report Number: 3004893332-2025-00004
• Device Sequence Number: 8467326
• Product Code: KWQ
• UDI-Device Identifier: 00840606108232
• UDI-Public: 00840606108232
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K201029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 27140-016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 06/18/2025
• 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
• Patient Age: 49 YR
• Patient Sex: Male