ASCEND VBR SYSTEM
Received Jun 6, 2025 · Event occurred May 9, 2025
Report 2027467-2025-00094 · MDR key 22161940
Device
Generic name
Spinal Vertebral Body Replacement Device - Cervical
Manufacturer
Alphatec Spine, Inc.Model number
155-0-12-35Catalog number
155-0-12-35
Product problems
- Migration
- Migration
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE EXPLANT HAS NOT RETURNED FOR EVALUATION. PHOTOGRAPHS WERE NOT PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS THE IDENTIFYING LOT NUMBER WAS NOT PROVIDED. ALPHATEC SPINE IS SUBMITTING THIS REPORT TO COMPLY WITH THE FDA REGULATIONS 21 CFR 803. ALPHATEC SPINE HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS AVAILABLE. ANY FIELD THAT IS LEFT BLANK WAS NOT KNOWN AT THE TIME OF THIS SUBMISSION. IF ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
AT THE 1-WEEK POSTOPERATIVE VISIT, A SLIGHT POSTERIOR SHIFT OF THE CAGE WAS NOTED. THE CAGE WAS REMOVED DURING REVISION SURGERY.