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

Model Number 15025-075-050

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 07/27/2021

Event Type  malfunction  

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 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
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE, INC; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: jayson alaba ; 1950 camino vida roble; carlsbad, CA 92008 ; 7604946771
• MDR Report Key: 12372150
• MDR Text Key: 271129951
• Report Number: 2027467-2021-00061
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00190376117034
• UDI-Public: (01)00190376117034
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 15025-075-050
• Device Catalogue Number: 15025-075-050
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2021
• 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