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

Model Number	15100
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Around one year after the initial surgery, the patient underwent revision surgery to extend the existing construct.During the procedure, it was observed that one of the previously implanted set screws had backed out, while another was found to be loose.Both set screws were removed and replaced.This is report 1 of 2.
Additional Manufacturer Narrative
The explant is currently being evaluated.A follow-up report with the results of the investigation will be submitted upon completion.
Additional Manufacturer Narrative
Correction: h3.Yes.H6.Investigation findings: 3243.Investigation conclusions: 61.Device evaluation: visual inspection of the set screw showed the presence of a starburst wear pattern around the circumference, whereas typical set screw wear has an even hourglass wear pattern.These wear marks indicate excessive or unintended motion in the rod-set screw contact which is caused by a set screw backout.Additionally, there is an offset horizontal wear mark which indicates non-centralized loading of the set screw which is the result of rod movement against a cross-threaded set screw.Review of device history records showed no manufacturing or processing related irregularities.Labeling review: warnings/cautions/precautions: risks identified with the use of these devices, which may require additional surgery, include device component failure, loss of fixation/stabilization, non-union, vertebral fracture, neurological injury, vascular or visceral injury.Possible adverse effects: initial or delayed loosening, disassembly, bending, dislocation, and/or breakage of device components.Intraoperative management: final tightening of set screws: all set screws must be tightened using the appropriate instruments (e.G., torque handle, final driver, and counter torque) as indicated in the surgical technique guide.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: KODIAK 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: wesley channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 21381157
• Report Number: 2027467-2025-00025
• Device Sequence Number: 8388262
• Product Code: NKB
• UDI-Device Identifier: 00190376137902
• UDI-Public: (01)00190376137902(10)AP01413
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K181677
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/13/2025

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: 15100
• Device Catalogue Number: 15100
• Device Lot Number: AP01413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2023
• 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: Other
• Patient Sex: Unknown