IDENTITI NANOTEC
Received Apr 27, 2026 · Event occurred Mar 30, 2026
Report 2027467-2026-00099 · MDR key 25005707
Device
Generic name
Intervertebral Fusion Device With Bone Graft, Cervical
Manufacturer
Alphatec Spine, Inc.Model number
126-PRO-06161407-SCatalog number
126-PRO-06161407-S
Product problems
- Migration or Expulsion of Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE IMPLANT REMAINS IN SITU, AND THERE ARE NO PLANS FOR REVISION SURGERY. RADIOGRAPHIC IMAGES WERE PROVIDED AND CONFIRMS THE REPORTED EVENT. RADIOGRAPHIC IMAGING INDICATES SUBSIDENCE OF THE CAGE. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE COULD NOT BE DETERMINED.
Description of Event or Problem
DURING A POSTOPERATIVE FOLLOW-UP VISIT, RADIOGRAPHIC IMAGING REVEALED SCREW MIGRATION FROM THE BONE, RESULTING IN ANTERIOR MIGRATION OF THE PLATE AND EXPULSION OF THE INTERBODY CAGE. THIS IS REPORT 2 OF 2.