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

Device Problems Failure to Osseointegrate (1863); Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 01/05/2023

Event Type  malfunction  

Manufacturer Narrative

Radiographs received confirming the event, depict bone screw backing out of c7 at 3 weeks.Device was not returned and could not be evaluated.This is no plan for revision, as the patient is asymptomatic 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 Description

On (b)(6) 2022, patient underwent anterior cervical fusion (acdf) surgery with a one level anterior cervical plate (acp) c6-c7.Reportedly during routine follow up on (b)(6) 2023 radiographs depicted the c7 bone screw on the acp had backed out.Patient is asymptomatic.The patient will continued to be monitored and there is no plan for revision.

• Brand Name: SAPPHIRE
• Type of Device: 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: 16656471
• MDR Text Key: 312550867
• Report Number: 3004893332-2023-00001
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Female