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

Catalog Number	63485-090 63085-050
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3004893332-2024-00001
• Device Sequence Number: 18185905
• Product Code: NKB
• UDI-Device Identifier: 00840606101295
• UDI-Public: 00840606101295
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K191576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 03/07/2024

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: 63485-090 63085-050
• 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: 02/29/2024
• Initial Report FDA Received Date: 03/07/2024
• 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 Sex: Unknown