MAUDE Adverse Event Report: SPINAL ELEMENTS, INC. MERCURY CLASSIC; MERCURY STRAIGHT ROD 5.5MM X 400MM

Device Problems Fracture (1260); Misconnection (1399)

Patient Problem No Information (3190)

Event Date 03/21/2017

Event Type  Injury  

Manufacturer Narrative

Patient kept device.

Event Description

Revision surgery performed to remove mercury straight rod 400mm that had fractured between l1 and l2 at the interface with the rod-to-rod connectors.Original surgery took place in (b)(6) 2016 with an unsuccessful fusion.

• Brand Name: MERCURY CLASSIC
• Type of Device: MERCURY STRAIGHT ROD 5.5MM X 400MM
• 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: 6481803
• MDR Text Key: 72797853
• Report Number: 3004893332-2017-00007
• Device Sequence Number: 1
• Product Code: NKB
• 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,Followup
• Report Date: 04/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/27/2017
• Date Manufacturer Received: 03/27/2017
• 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