MAUDE Adverse Event Report: ALPHATEC SPINE, INC. INVICTUS; SCREWDRIVER

Model Number 17950-225

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/26/2024

Event Type  Injury  

Manufacturer Narrative

The device has not returned for evaluation.Photographs were not provided; therefore, the event could not be confirmed.The identifying lot number was not provided; therefore, a review of the device history record could not be conducted.Based on the information provided the root cause cannot be determined.

Event Description

The tip of the driver broke off during a case.The tip was left in the screw shank which remians in the patient.There was no report of patient symptoms or complications due to this event.

• Brand Name: INVICTUS
• Type of Device: SCREWDRIVER
• 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
• MDR Report Key: 18761625
• MDR Text Key: 336023148
• Report Number: 2027467-2024-00009
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 17950-225
• Device Catalogue Number: 17950-225
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/26/2024
• Initial Date FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1