RESOLVE HALO
Received Jun 9, 2021 · Event occurred May 11, 2021
Report 1836248-2021-00001 · MDR key 11967400
Device
Product problems
- Use of Device Problem
- Unintended Movement
Patient
Unknown
- Unspecified Infection
- Unspecified Infection
Narrative
Description of Event or Problem
A PATIENT FITTED WITH HALO HAD PROBLEMS WITH A PIN SITE OVER THE DURATION OF THE USE AND THE PIN HAD TO BE REPLACED DUE TO SKULL BREACH. IT HAS NOT BEEN CONFIRMED THAT THE PIN SITE BREACH CONTRIBUTED TO THE EVENT SINCE THERE WERE NO EVIDENCE OF INFECTION. THE DEVICE WAS REMOVED AFTER 12 WEEK USE BUT 10 DAYS AFTER REMOVING THE DEVICE THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT AT HIS LOCAL HOSPITAL WITH A POTENTIAL CNS INFECTION. THE PATIENT PASSED AWAY ON JUNE 21ST.
Description of Event or Problem
A PATIENT FITTED WITH HALO HAD PROBLEMS WITH A PIN SITE OVER THE DURATION OF THE USE AND THE PIN HAD TO BE REPLACED DUE TO SKULL BREACH. IT HAS NOT BEEN CONFIRMED THAT THE PIN SITE BREACH CONTRIBUTED TO THE EVENT SINCE THERE WERE NO EVIDENCE OF INFECTION. THE DEVICE WAS REMOVED AFTER 12 WEEK USE BUT 10 DAYS AFTER REMOVING THE DEVICE THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT AT HIS LOCAL HOSPITAL WITH A POTENTIAL CNS INFECTION. THE PATIENT PASSED AWAY ON JUNE 21ST.
Additional Manufacturer Narrative
THE PATIENT WAS PLACED IN A HALO DUE TO FALL CAUSING A FRACTURE ON THE C2. AT 4 WEEKS PIN PENETRATION OCCURRED, WHERE THE PIN WAS REMOVED AND RE-SITED. AT 12 WEEKS THE HALO WAS REMOVED, AND 10 DAYS LATER THE PATIENT WAS ADMITTED TO THE ICU. CNS INFECTION WAS SUSPECTED, BUT NOT CONFIRMED. WITHIN 2 WEEKS THE PATIENT PASSED AWAY. THE DEVICE WAS NOT RETURNED FOR ANALYSIS, SO PRODUCT FAILURE OR MALFUNCTION COULD NOT CONFIRMED. THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE ROOT CAUSE AND WHETHER THE HALO CONTRIBUTED TO THE PATIENT BEING ADMITTED TO THE ICU. THE CAUSE OF DEATH IS UNKNOWN AND THE AUTOPSY REPORT HAS NOT BEEN PROVIDED. THE LIKELIHOOD OF THIS TYPE OF FAILURE LEADING TO A HAZARDOUS EVENT RESULTING IN A SERIOUS OR CATASTROPHIC INJURY IS CONSIDERED REMOTE. WE WILL CONTINUE TO MONITOR THIS ISSUE.
Description of Event or Problem
A PATIENT FITTED WITH HALO HAD PROBLEMS WITH THE PIN SITES OVER THE DURATION OF THE USE AND THE PINS HAD TO BE REPLACED DUE TO SKULL BREACHES. THE DEVICE WAS REMOVED BUT AFTER 10 DAYS THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT AT HIS LOCAL HOSPITAL WITH A POTENTIAL CNS INFECTION. IT HAS NOT BEEN CONFIRMED THAT THE PIN SITE BREACH CONTRIBUTED TO THE EVENT.
Remedial action
- Patient Monitoring