MAUDE Adverse Event Report: SPINAL ELEMENTS, INC. MERCURY; MERCURY STRAIGHT ROD

Device Problems Break (1069); Fracture (1260); Human Factors Issue (2948)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)

Event Date 01/10/2017

Event Type  malfunction  

Manufacturer Narrative

Patient insisted on keeping the devices.

Event Description

Physician performed a revision surgery on patient to remove two (2) broken straight rods around l2-l3.Original surgery was performed 1 year ago and a follow up procedure was done 3 months ago to extend the lumbar fusion from 4 level to 6 level.Physician believes that it was a stress fracture due to the patient removing their brace prematurely.

• Brand Name: MERCURY
• Type of Device: MERCURY STRAIGHT ROD
• Manufacturer (Section D): SPINAL ELEMENTS, INC.; 3115 melrose drive, suite 200; carlsbad CA 92010
• Manufacturer Contact: julie lamothe ; 3115 melrose drive, suite 200; carlsbad, CA 92010 ; 7606071816
• MDR Report Key: 6251772
• MDR Text Key: 65214883
• Report Number: 3004893332-2017-00001
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/10/2017
• Date Manufacturer Received: 01/10/2017
• 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
• Patient Outcome(s): Other