MAUDE Adverse Event Report: ALPHATEC SPINE, INC INVICTUS SPINAL FIXATION SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	15025-075-050
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not returned for evaluation.A photograph was provided confirming the event.It was reported the break may have been caused by the screw being against the psis (posterior superior iliac spine) and the patient had unreasonably hard bone.The screw was placed at s1.A snap was heard when driving the screw into bone.The screw was retrieved using a t-adjuster.Upon the receipt of additional information and/or the device in question, a follow-up report will be submitted."labeling review: possible adverse effects: the following complications and adverse reactions have been shown to occur with the use of similar spinal instrumentation.These effects and any other known by the surgeon must be discussed with the patient preoperatively.Initial or delayed loosening, disassembly, bending, dislocation, and/or breakage of device components.".
Event or Problem Description
A mis reduction screw tulip broke prematurely at the distal weld and break point during surgery.The screw was being placed at s1.It was removed from the patient.No patient injury reported.

• Brand Name: INVICTUS SPINAL FIXATION SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE, INC; 1950 camino vida roble; carlsbad CA 92008
• MDR Report Key: 12372150
• Report Number: 2027467-2021-00061
• Device Sequence Number: 19745767
• Product Code: NKB
• UDI-Device Identifier: 00190376117034
• UDI-Public: (01)00190376117034
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K203056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2021

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: No Information
• Device Model Number: 15025-075-050
• Device Catalogue Number: 15025-075-050
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1