MAUDE Adverse Event Report: ALPHATEC SPINE, INC. TRESTLE LUXE II ANTERIOR CERVICAL PLATING SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	722-14014
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Numbness (2415)
Date of Event	10/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent a surgical procedure on (b)(6) 2020.Following surgery and upon resuming normal daily activities, the patient began to experience numbness and tingling and similar symptoms.Over time, the pain progressively worsened and became unbearable.The patient sought medical evaluation and was subsequently informed that the pedicle screw had broken.
Additional Manufacturer Narrative
The screw has not returned for evaluation.It is unknown if revision surgery occurred.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.Any required fields left blank were not known at the time of this submission.

• Brand Name: TRESTLE LUXE II ANTERIOR CERVICAL PLATING SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• 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: 23438107
• Report Number: 2027467-2025-00198
• Device Sequence Number: 8625480
• Product Code: KWQ
• UDI-Device Identifier: 00190376217741
• UDI-Public: (01)00190376217741(10)8367903
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 10/31/2025

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: 722-14014
• Device Catalogue Number: 722-14014
• Device Lot Number: 8367903
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2019
• 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 Age: 30 YR
• Patient Sex: Female