MAUDE Adverse Event Report: ALPHATEC SPINE, INC. INVICTUS SPINAL FIXATION SYSTEM; LXH

Model Number 17167-045; 17165

Device Problems Entrapment of Device (1212); Mechanical Problem (1384); Separation Failure (2547); Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 05/12/2021

Event Type  Injury  

Manufacturer Narrative

The returned device is currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.

Event Description

Single step adapter and screw will not disassemble.Looks like the guidewire bent and got stuck in the screw and will not come apart.The surgeon attempted to disassemble for approximately 45 minutes; however, it will not come apart.

Manufacturer Narrative

Atec received a complaint on 05/12/2021 reporting the single step adapter and screw would not disassemble which resulted in a 45 minute delay in surgery.The invictus single step adapter (17165), mis reduction locking polyaxial screwdriver (17111), cannulated extended tab polyaxial reduction screw 6.5mm x 45mm (15025-065-045) & 45mm single step stylet, bevel (17167-045) were returned to atec on 05/17/2021.Visual inspection confirmed the instruments and implant were all assembled together and unable to be disassembled.The assembly was able to be disassembled by forcibly removing the stylet from the screw by malleting on the assembly while the stylet distal tip was held in a vice.The stylet had been bent/kinked at the distal end.This most likely occurred from exposing the stylet from the distal end of the screw and applying excessive lateral force to the stylet.The bend/kink create an interference with the cannulation of the screw preventing disassembly of the instruments and implant.

• Brand Name: INVICTUS SPINAL FIXATION SYSTEM
• Type of Device: LXH
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• MDR Report Key: 11980283
• MDR Text Key: 255594002
• Report Number: 2027467-2021-00035
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 17167-045; 17165
• Device Catalogue Number: 17167-045; 17165
• Device Lot Number: 8405303; 8519415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Date Manufacturer Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization