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

Model Number 63485-090

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 10/30/2020

Event Type  malfunction  

Manufacturer Narrative

Radiographic imaging depicts the screw shank in the iliac has separated from the screw head (tulip) which is still attached to the rod.The device was not returned as it remains in-situ and therefore could not be evaluated.Unknown factors include: patient activity at the time or prior to the event, patient bone quality, 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.).Patient was noted to be morbidly obese.Root cause or specific failure mode cannot be determined.Labeling review notes: "possible adverse events.Disassembly, bending, and/or breakage of any or all of the components.Loss of fixation.".

Event Description

Patient received a spinal fusion surgery (plif) with bilateral fixation from t10-pelvis.Initial surgery date was (b)(6) 2020.During routine follow up visit 6 weeks post-operatively, radiographs depicted a tulip/head separation from the iliac bolt on the left side.Patient is asytomatic.There is no plan for revision unless patient presents with non-union at l5-s1, or sacral fracture.

• 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 ; 7606071830
• MDR Report Key: 10906301
• MDR Text Key: 240379826
• Report Number: 3004893332-2020-00013
• 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: K141372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/30/2020

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
• Device Operator: Health Professional
• Device Model Number: 63485-090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2020
• Initial Date FDA Received: 11/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2018
• 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: 56 YR