MalfunctionGWF
SafeOp 1.5 Head Unit
Received Jul 27, 2026 · Event occurred Jun 26, 2026
Report 2027467-2026-00155 · MDR key 50015096
Add to watch list
Product code (GWF)
Manufacturer (Alphatec Spine, Inc.)
Model (AIX11901)
Device
Generic name
Stimulator, Electrical, Evoked Response
Manufacturer
Alphatec Spine, Inc.Model number
AIX11901Catalog number
AIX11901
Product problems
- Failure to Charge
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
During a spinal procedure using intraoperative neuromonitoring, it was reported that the system had a damaged power port. This made the system inoperable. A second neuromonitoring system had to be used to complete the surgery.
Additional Manufacturer Narrative
The system is returning for evaluation. A follow-up report with the results of the investigation will be submitted upon completion.