MAUDE Adverse Event Report: ALPHATEC SPINE, INC. ASCEND VBR SYSTEM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE - CERVICAL

Model Number	156-12-200
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is 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 driver was having difficulty expanding an implant during a spinal procedure.The implant was left in the patient with no complications.Once the case was completed, it was noticed that the inserter was stripped.
Event or Problem Description
It was reported that the driver was having difficulty expanding an implant during a spinal procedure.The implant was left in the patient with no complications.Once the case was completed, it was noticed that the inserter was stripped.
Additional Manufacturer Narrative
Visual inspection confirms the complaint.The distal gear form of the driver shows damage consistent with wear that prevents the interface with the gear teeth of an implant.The root cause is likely excessive input torque.Review of device history records showed no manufacturing or processing related irregularities that would cause or contribute to this failure mode.Labeling review: warnings/cautions/precautions: potential risks identified with the use of these devices, which may require additional surgery, include device component failure, loss of fixation, pseudarthrosis (i.E., non-union), fracture of the vertebra, neurological injury, and/or vascular or visceral injury.Possible adverse effects: initial or delayed loosening, bending, dislocation, and/or breakage of device components.

• Brand Name: ASCEND VBR SYSTEM
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE - CERVICAL
• 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: 24464748
• Report Number: 2027467-2026-00029
• Device Sequence Number: 18711535
• Product Code: PLR
• UDI-Device Identifier: 00190376517957
• UDI-Public: (01)00190376517957(10)EM51956
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K232173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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: 156-12-200
• Device Catalogue Number: 156-12-200
• Device Lot Number: EM51956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown