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

Model Number 15100

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Pain (1994)

Event Date 11/21/2022

Event Type  malfunction  

Manufacturer Narrative

Radiograph images were provided to confirm the event.The implant remains in the patient.The identifying lot number was not provided; therefore, the device history records could not be reviewed.Based on the information provided, a root cause could not be determined.There are warnings in the device labeling that this type of event can occur.Labeling review: intraoperative management: final tightening of set screws: all set screws must be tightened using the appropriate instruments (e.G., torque handle, final driver, and counter torque) as indicated in the surgical technique guide.Warnings/cautions/precautions: risks identified with the use of these devices, which may require additional surgery, include device component failure, loss of fixation/stabilization, non-union, vertebral fracture, neurological injury, vascular or visceral injury.Do not final tighten under compression or distraction as the rod may not be normalized to the tulips, resulting in rod slippage.Failure to tighten set screws using the recommended instrument(s) could compromise the mechanical stability of the construct.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.Infection.

Event Description

Information was received indicating a patient underwent a revision surgery to extend prior construct at l4-5 to l3-s1.A transforaminal lumbar interbody fusion was performed at l5-s1.Around 6-weeks postop, a radiograph image revealed a right set screw loosening/rod dissociation and subsequent l5-s1 intradiscal infection.Patient is reporting lower left extremity radiculopathy.There are no plans for revision surgery.The surgeon will continue to monitor the patient.

• Brand Name: INVICTUS
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer (Section G): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: wesley channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 16019616
• MDR Text Key: 308125423
• Report Number: 2027467-2022-00098
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 15100
• Device Catalogue Number: 15100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2022
• 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