ASCEND VBR SYSTEM
Received Feb 26, 2026 · Event occurred Jan 30, 2026
Report 2027467-2026-00029 · MDR key 24464748
Device
Generic name
Spinal Vertebral Body Replacement Device - Cervical
Manufacturer
Alphatec Spine, Inc.Model number
156-12-200Catalog number
156-12-200
Lot number
EM51956
Product problems
- Material Twisted/Bent
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
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.
Additional Manufacturer Narrative
THE DEVICE IS CURRENTLY BEING EVALUATED. A FOLLOW-UP REPORT WITH THE RESULTS OF THE INVESTIGATION WILL BE SUBMITTED UPON COMPLETION.
Description of Event or Problem
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.