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

Model Number	15025-075-045
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Codes	Failure of Implant (1924); Foreign Body In Patient (2687)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The implant and distal portion of the extended tabs remain in the patient; therefore, no product evaluation can be conducted.A review of the device history records could not be performed as the identifying lot number was not provided.A radiograph image confirmed the event.It is unknown if fluoroscopic imaging was used during the procedure to confirm that the distal tabs were properly removed.Based on the information available, a root cause cannot be determined.Alphatec spine is submitting this report to comply with the fda regulations 21 cfr 803.Alphatec spine has made reasonable efforts to provide as much relevant information as available.Any field that is left blank was not known at the time of this submission.If additional information is provided, a supplemental report will be submitted.
Event or Problem Description
A male patient underwent a spinal procedure where posterior fixation was implanted from l3 to s1.During a postoperative follow-up, a radiograph image revealed the bilateral screws at s1 still had the distal portion of the extended tabs attached to the screw tulip.It was reported the patient is asymptomatic, and there are no plans for revision surgery.This is report 1 of 2.

• 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: 20432162
• Report Number: 2027467-2024-00137
• Device Sequence Number: 12888361
• Product Code: NKB
• UDI-Device Identifier: 00190376117027
• UDI-Public: (01)00190376117027
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K181677
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/11/2024

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: 15025-075-045
• Device Catalogue Number: 15025-075-045
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male