InjuryJAA
C-ARM
Received Jul 10, 2026
Report MW5190567 · MDR key 25778279
Device
Generic name
System, X-ray, Fluoroscopic, Image-intensified
Manufacturer
UnknownPatient
NA · Unknown
- Insufficient Information
Narrative
Description of Event or Problem
(B)(6) ((B)(6) REP) CALLED TO REPORT THAT AFTER SUCCESSFULLY COMPLETING THE C-ARM CALIBRATION FOR AN L5-S1 OPEN CASE WITH HYBRID REFERENCE FRAME, THEY HAVE DIFFICULTIES REGISTERING. HE STATES IT TOOK 30 MINUTES OF TROUBLESHOOTING AND TAKING NEW IMAGES FOR THE REGISTRATION TO PASS. THEIR IMAGES INCLUDED LEVELS FROM L3 TO PELVIS. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).