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

Model Number	77635-45
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection under microscope reviewed wear that is typically seen on the set screw to rod interface.The wear present did not seem to indicate the set screw was torqued down to the recommended torque limit.The device was also set-up in a construct to evaluate performance in placement in the pedicle screw.No failures detected throughout this investigation process.Malfunction of device could not be confirmed.It is believed at this point that not enough torque was applied to the set screws.
Event or Problem Description
Original pedicle screw construct case was completed for a 2-level tlif on (b)(6) 2016.On (b)(6) 2016 during a follow-up visit with the patient, the surgeon allegedly identified 2 set screws had backed out of the pedicle screws in the construct.A removal case was completed on (b)(6) 2017 at which time the manufacturer was notified of the occurence.

• Brand Name: TIGER SPINE SYSTEM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): CORELINK, LLC; 7911 forsyth blvd; suite 200; saint louis MO 63105
• MDR Report Key: 6379913
• Report Number: 3006494201-2017-00006
• Device Sequence Number: 16281805
• Product Code: MNI
• UDI-Device Identifier: M72577635450
• UDI-Public: +M72577635450/$$7SM67580E
• Combination Product (Y/N): N
• PMA/510(K) Number: K131250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2017

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
• Operator of Device: Physician
• Device Model Number: 77635-45
• Device Catalogue Number: 77635-45
• Device Lot Number: SM67580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2017
• Initial Report FDA Received Date: 03/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1