MAUDE Adverse Event Report: SPINAL ELEMENTS, INC. MERCURY CLASSIC; MERCURY CLASSIC POLYAXIAL SCREW 8.5MM X 45MM

Catalog Number 62085-045

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 07/19/2016

Event Type  malfunction  

Event Description

Polyaxial heads from two screw assemblies discovered to be disassociated during revision surgery.Parts were able to be retrieved from patient.

• Brand Name: MERCURY CLASSIC
• Type of Device: MERCURY CLASSIC POLYAXIAL SCREW 8.5MM X 45MM
• 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: 5841930
• MDR Text Key: 52070632
• Report Number: 3004893332-2016-00006
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K083230
• 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: 08/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 62085-045
• Device Lot Number: 080453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/19/2016
• Initial Date Manufacturer Received: 07/19/2016
• Initial Date FDA Received: 08/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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