MAUDE Adverse Event Report: ALPHATEC SPINE, INC. INVICTUS SPINAL FIXATION SYSTEM; BONE CEMENT, POSTERIOR SCREW AUGMENTATION

Model Number	55203-075-045
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
About 4 days postoperatively, it was reported that the screw had medially breached the pedicle.The patient underwent a revision surgery to remove the screw.
Additional Manufacturer Narrative
The screw has not returned for evaluation.Radiographic images were not provided.A review of the device history records could not be performed as the identifying lot number was not provided.Based on the information provided, the root cause could not 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.

• Brand Name: INVICTUS SPINAL FIXATION SYSTEM
• Common Device Name: BONE CEMENT, POSTERIOR SCREW AUGMENTATION
• 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: michael hendrickson ; 1950 camino vida roble; carlsbad, CA 92008 ; 7603566777
• MDR Report Key: 22853612
• Report Number: 2027467-2025-00204
• Device Sequence Number: 8457626
• Product Code: PML
• UDI-Device Identifier: 00190376424637
• UDI-Public: (01)00190376424637
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K221926
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2025

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
• Operator of Device: Health Professional
• Device Model Number: 55203-075-045
• Device Catalogue Number: 55203-075-045
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 08/20/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male