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

Model Number	27340-014
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographs received confirmed the event.Images depicted fractured bone screws at c5 and that fusion had occurred (per the surgeon.) devices were not returned and could not be evaluated.This is no plan for revision, as the patient is fused and doing fine.Unknown factors include: patient activity at the time or prior to the event, the degree of spinal instability or patient compliance with post-operative care instructions or if the patient sustained a fall/impact of any sort (no trauma was reported).Root cause is unknown.
Event or Problem Description
On (b)(6) 2021, patient underwent anterior cervical fusion (acdf) surgery with a one level anterior cervical plate (acp) c4-c5.Patient had follow-up on (b)(6)2021 and was fine.On (b)(6) 2022 follow up, radiographs depicted the c5 bone screws on the acp had fractured.Patient had fused and was asymptomatic.There is no plan for revision surgery.

• 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 ; 3115 melrose drive, suite 200; carlsbad, CA 92010 ; 7606071830
• MDR Report Key: 13727177
• Report Number: 3004893332-2022-00006
• Device Sequence Number: 11865900
• Product Code: KWQ
• UDI-Device Identifier: 00840606108430
• UDI-Public: 00840606108430
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K201029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 03/11/2022

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 Model Number: 27340-014
• Device Catalogue Number: 27340-014
• 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: 02/15/2022
• Initial Report FDA Received Date: 03/10/2022
• 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: 35 YR
• Patient Sex: Male