MalfunctionGZT
BUDDE HALO RETRACTOR A1040
Received Mar 30, 2026 · Event occurred Jan 17, 2026
Report 3004608878-2026-00038 · MDR key 24715406
Device
Product problems
- Unstable
Patient
40 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A FACILITY REPORTED THAT DURING A BRAIN TUMOR RESECTION, THE HALO FLEX ARM OF THE BUDDE HALO RETRACTOR SYSTEM (A1040) WAS NOT TIGHTENING. THERE WAS NO PATIENT INJURY; HOWEVER, THERE WAS SURGICAL DELAY OF AN HOUR.
Additional Manufacturer Narrative
AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.