BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLVE HALO

    MDR report key: 11967400 · Received June 9, 2021

    Report

    Report Number
    1836248-2021-00001
    Event Type
    Death
    Date Received
    June 9, 2021
    Date of Event
    May 11, 2021
    Report Date
    December 1, 2021
    Manufacturer
    OSSUR AMERICAS
    Product Code
    LYT
    UDI-DI
    05690977308657
    PMA / PMN Number
    K040363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    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 · 0

    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 · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867265 RESOLVE HALO TRACTION DEVICE LYT OSSUR AMERICAS 515400D 05690977308657

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| D