MAUDE Adverse Event Report: CORELINK, LLC TIGER; PEDICLE SCREW

Model Number 5500

Device Problems Degraded (1153); Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 02/28/2014

Event Type  malfunction  

Manufacturer Narrative

No further information could be obtained on the use or the scenario in how this occurred.

Event Description

During a surgery on (b)(6) 2014 the surgeon performed a revision surgery for a screw that fractured within the body cavity.The level above the screw had degenerated.The fractured screw was removed and the surgeon re-instrumented the disc space.

• Brand Name: TIGER
• Type of Device: PEDICLE SCREW
• Manufacturer (Section D): CORELINK, LLC; st. louis MO
• Manufacturer Contact: 7606 forsyth blvd.; st. louis, MO 63105 ; 3148635401
• MDR Report Key: 4961336
• MDR Text Key: 23155112
• Report Number: 1935627-2015-00002
• Device Sequence Number: 1
• Product Code: MCV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110321
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Report Date: 07/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5500
• Device Catalogue Number: 55075-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2014
• 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
• Patient Outcome(s): Required Intervention