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

Model Number	16196-045
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is currently being evaluated.A follow-up report with the results of the investigation will be submitted upon completion.
Event or Problem Description
It was reported that the tip of the expansion shaft broke off in the expandable screw when it would not expand.The tip was retrieved from the patient.This is report 1 of 2.
Additional Manufacturer Narrative
This is report 1 of 2.Corrected information: h3.Yes.H6.Investigation findings: 3252.Investigation conclusion: 4307, 18, 61.Visual inspection confirms that the distal threaded tip of the expansion driver sheared off.The osseoscrew was not able to expand, meaning that the expansion shaft was likely under high tension.The root cause of the expansion shaft shearing off is due to this high tension along with torsional stresses applied.Review of device history records showed no manufacturing or processing related irregularities.Labeling review: possible adverse effects: initial or delayed loosening, disassembly, bending, dislocation and/or breakage of device components.

• Brand Name: INVICTUS
• Common Device Name: 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: 20157601
• Report Number: 2027467-2024-00091
• Device Sequence Number: 17202332
• Product Code: NKB
• UDI-Device Identifier: 00190376381633
• UDI-Public: (01)00190376381633(10)EM44832
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K202327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2024

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
• Operator of Device: Health Professional
• Device Model Number: 16196-045
• Device Catalogue Number: 16196-045
• Device Lot Number: EM44832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown