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

Model Number 15025-055-045;15025-065-045

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 05/02/2022

Event Type  malfunction  

Manufacturer Narrative

The implant has not returned to alphatec for evaluation.The identifying lot number was not provided; therefore, a review of the device history records could not be performed.Additional information was requested but no response has been received.The root cause could not be determined at this time.If additional information is received, a supplemental report will be submitted.Labeling review: "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.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.1.Initial or delayed loosening, disassembly, bending, dislocation, and/or breakage of device components".

Event Description

T7-11 fixation with pedicle screws at t9 for fracture stabilization.At the time of closing the surgical wound, the final step is to snap off the long titanium tabs that extend from the head of the screw and protrude several inches above the skin.The alphatec representative handed the surgeon the tool to break the tab with instructions as to how to proceed.The tabs were broken and not visible from the skin.A follow up x-ray showed a retained tab.Appropriate tool instrumentation was then given to the surgical team post-event.

• 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 92088
• Manufacturer Contact: wesley channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 15974087
• MDR Text Key: 308463250
• Report Number: 2027467-2022-00102
• 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: 12/13/2022

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
• Device Model Number: 15025-055-045;15025-065-045
• Device Catalogue Number: 15025-055-045;15025-065-045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2022
• Initial Date FDA Received: 12/13/2022
• 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
• Patient Age: 61 YR
• Patient Sex: Male