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

Model Number 63595-080

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

Patient Problem Failure of Implant (1924)

Event Date 10/20/2020

Event Type  Injury  

Event Description

Patient underwent spinal fusion surgery on (b)(6) 2019 to correct degenerative scoliosis from t8- pelvis with five interbody cages and competitive rod and screws.Approximately one year post operative in 2020 it was noted that the tulip separated from the iliac bone screw at s2.S1 bone screw was still intact, and patient was continued to be monitored for two more years.On (b)(6) 2022 patient was revised after competitive rod fractured at l1-l2.Iliac bone screw at s2 was then replaced.

Manufacturer Narrative

Radiographs depicting a tulip separation at s2 were received and confirmed the event.The subject iliac screw and tulip head were returned for evaluation.The evidence of final tightening suggested that the screw was at max angulation and rod was unevenly normalized in the head of the screw.The rod created wear marks inside the screw head suggesting the lock screw and rod had loosened (may have not reached final tightening) prior to the head disassembling from the screw shank.Device was not revised for two additional years until unrelated hardware failure occurred (l1-l2) prompting unrelated revision surgery in on (b)(6) 2022.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 patient trauma/impact /sustained a fall (patient fall was reported in 2020).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.".

• 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: 16039165
• MDR Text Key: 306039374
• Report Number: 3004893332-2022-00015
• 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: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 63595-080
• Device Catalogue Number: 63595-080
• Device Lot Number: 190025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male