MAUDE Adverse Event Report: CORELINK, LLC TIGER MIS SPINE SYSTEM; ORHOSIS, SPINAL PEDICLE FIXATION

Model Number 77635-45

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/14/2016

Event Type  malfunction  

Manufacturer Narrative

Manufacturer was made aware of the set screw backing out of the construct, but later told it was apparent the cause was cross threading.Product lot number was not identified to the manufacturer.Intent for revision surgery was also not identified to the manufacturer.Device not returned.

Event Description

On (b)(6) 2016 it was identified to the company that a set screw ((b)(4)) had possibly backed out of the construct for the tiger mis spine system.It was later reported that further x-ray imaging during post-op review identified the set screw had cross-threaded.It is apparent through this information that user error upon implantation lead to this occurence.No adverse event was reported along with this instance, and no plans for revision surgery have been identified to the manufacturer at this time.

• Brand Name: TIGER MIS SPINE SYSTEM
• Type of Device: ORHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): CORELINK, LLC; 7911 forsyth blvd; suite 200; saint louis MO 63105
• Manufacturer (Section G): CORELINK, LLC; 7911 forsyth blvd; suite 200; saint louis MO 63105
• Manufacturer Contact: stephan jones ; 7911 forsyth blvd; suite 200; saint louis, MO 63105 ; 8883497808
• MDR Report Key: 6306080
• MDR Text Key: 66658431
• Report Number: 3006494201-2017-00005
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/06/2017

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: Physician
• Device Model Number: 77635-45
• Device Catalogue Number: 77635-45
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2016
• Initial Date FDA Received: 02/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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