MAUDE Adverse Event Report: SPINAL ELEMENTS, INC MERCURY; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 03/11/2024

Event Type  malfunction  

Manufacturer Narrative

Radiograph was received depicting a left iliac tulip separation from the bone screw shank, confirming the event.No index surgery information or product information provided.The subject screw and tulip head were not returned for evaluation as they remain in the patient.The patient is asymptomatic and there is no revision planned at this time.Unknown factors include: patient activity at the time or prior to the event, the degree of spinal instability, the degree of pseudarthrosis, 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 or specific failure mode cannot be determined.

Event Description

Patient underwent posterior lumbar spinal fusion surgery from l2- pelvis.Initial surgery date was not provided.During routine follow up, it was noted that the tulip head separated from the left iliac bone screw.Patient is asymptomatic and there is no plan for revision surgery at this time.

• Brand Name: MERCURY
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW 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
• MDR Report Key: 19043289
• MDR Text Key: 339394085
• Report Number: 3004893332-2024-00003
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191576
• 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: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2024
• 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: 03/11/2024
• 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