HALSTEAD FCPS 5 CVD MIRROR
Received Jan 10, 2012 · Event occurred Jan 5, 2012
Report 2523190-2012-00007 · MDR key 2433652
Device
Product problems
- Break
- Detachment Of Device Component
Patient
Not reported
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
PER CUSTOMER - TIP BROKE OFF DURING SURGERY. ON (B)(6) 2012 PER THE MATERIALS COORDINATOR, DURING A LUMBAR SPINE STIMULATOR SURGERY, ONE SIDE OF THE CLAMP WAS DISCOVERED TO BE MISSING WHEN THE SURGEON HANDED BACK THE DEVICE TO ASSISTANT DURING THE SURGERY. THE SURGERY WAS DELAYED FOR "A FEW MINUTES" FOR AN X-RAY TO BE TAKEN, THE MISSING TIP WAS NOT VISUALIZED ON X-RAY. NO FURTHER TREATMENT WAS PROVIDED. A VISUAL CHECK OF THE SURGICAL FIELD AND SURROUNDING AREA WAS PERFORMED; THE TIP OF THE DEVICE WAS NOT FOUND.
Additional Manufacturer Narrative
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.