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

Catalog Number 63485-090 63085-050

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

Patient Problem Failure of Implant (1924)

Event Date 02/29/2024

Event Type  malfunction  

Manufacturer Narrative

Radiographs were received depicting two tulip separations.One of the iliac/pelvic screw and one of s1 bone screw both on the left side; confirming the event.The subject screws and tulip heads were not returned for evaluation as the patient is asymptomatic and no revision is planned at this time.Root cause or specific failure mode cannot be determined.Labeling review notes: "possible adverse events.2.Disassembly, bending, and/or breakage of any or all of the components.3.Loss of fixation.".

Event Description

Patient underwent four level spinal fusion surgery on (b)(6) 2024 l2- pelvis.During routine six week follow up, it was noted that the tulip head separated from the iliac bone screw and the s1 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: 18858779
• MDR Text Key: 337187005
• Report Number: 3004893332-2024-00001
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00840606101295
• UDI-Public: 00840606101295
• 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: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 63485-090 63085-050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• 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