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

Catalog Number 15025-055-045, 15025-065-045

Device Problems Product Quality Problem (1506); Failure to Disconnect (2541)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/02/2022

Event Type  malfunction  

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.Manufacturer response for pedicle screws, atec 5.5 x 45 screw and 5.5x 45 screw (per site reporter) the representative.

• Brand Name: INVICTUS
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• MDR Report Key: 15787658
• MDR Text Key: 303545444
• Report Number: 15787658
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 15025-055-045, 15025-065-045
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/03/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22265 DA
• Patient Sex: Male
• Patient Race: White