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

Model Number	15600
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explants are 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 modular tulip had disengaged from the shank three days postoperatively.The original surgery was on (b)(6) 2025.Revision surgery occurred on (b)(6) 2025 to remove the tulip, rod, and set screw.
Additional Manufacturer Narrative
Correction: h3.Yes.H6.Investigation findings: 3207, 3211.Investigation conclusions: 61.Device evaluation: the collet of the tulip has been rotated 90 degrees clockwise from its normal loaded and deployed condition.Wear marks on the inside of the tulip body suggest that the tulip was properly deployed initially then rotated 90 degrees post deployment.With the collet pushed through the bottom of the tulip, the connection strength of the collet and shank is reduced, allowing the shank to disengage from the tulip.Rotation of the collet in the tulip post deployment due to hubbing caused the collet wings to enter the rod slot.The wings of the collet fully entered the rod slot and thus were not able to withstand the reduction forces of the rod and set screw causing the collet to pull through the bottom of the tulip and lead to the eventual disengagement of the shank from the tulip.Labeling review: warnings/cautions/precautions: risk factors that may affect successful surgical outcomes include alcohol abuse, obesity, patients with poor bone, muscle and/or nerve quality.Patients who use tobacco or nicotine products should be advised of the consequences that an increased incidence of non-union has been reported with patients who use tobacco or nicotine products.Possible adverse effects: initial or delayed loosening, disassembly, bending, dislocation, and/or breakage of device components.Postoperative management: the surgeon should instruct the patient regarding amount and time frame after surgery of any weight bearing activity.The increased risk of bending, dislocation, and/or breakage of the implant devices, as well as an undesired surgical result are consequences of any type of early or excessive weight bearing, vibratory motion, fall, jolts or other movements preventing proper healing and/or fusion development.Implant devices should be revised or removed if bent, dislocated, or broken.Immobilization should be considered in order to prevent bending, dislocation, or breakage of the implant device in the case of delayed, mal-union, or non-union of bone.Immobilization should continue until a complete bone fusion mass has developed and been confirmed.

• Brand Name: INVICTUS SPINAL FIXATION SYSTEM
• 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: michael hendrickson ; 1950 camino vida roble; carlsbad, CA 92008 ; 7603566777
• MDR Report Key: 22810296
• Report Number: 2027467-2025-00197
• Device Sequence Number: 12712254
• Product Code: NKB
• UDI-Device Identifier: 00190376224756
• UDI-Public: (01)00190376224756(10)TO04836
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K192938
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 08/14/2025

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: 15600
• Device Catalogue Number: 15600
• Device Lot Number: TO04836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2025
• 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 Sex: Unknown