BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLVE HALO

    MDR report key: 9961409 · Received April 15, 2020

    Report

    Report Number
    0001836248-2020-00002
    Event Type
    Injury
    Date Received
    April 15, 2020
    Date of Event
    December 30, 2019
    Report Date
    March 17, 2020
    Manufacturer
    OSSUR AMERICAS
    Product Code
    HAX
    UDI-DI
    05690977308657
    PMA / PMN Number
    K051918
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INFORMATION KNOWN IT IS LIKELY NO FAILURE OR MALFUNCTION OCCURRED WITH THE DEVICE. THE EVENT LIKELY OCCURRED TO PIN PENETRATION, WHICH MAY HAVE BEEN DUE TO IMPROPER APPLICATION/MAINTENANCE OF THE PIN TIGHTNESS OR MAY HAVE BEEN DUE TO A FALL/IMPACT INCIDENT THAT WAS NOT RELATED TO A PRODUCT MALFUNCTION.

    Description of Event or Problem · 1

    THE PATIENT HAD A HALO VEST FITTED, THIS WAS READJUSTED TO IMPROVE ALIGNMENT A FEW DAYS LATER. THE PATIENT WAS SUBSEQUENTLY READMITTED WITH A SEIZURE. IMAGING CONFIRMED THE POSTERIOR HALO PINS HAD BREACHED THE SKULL BILATERALLY AND THERE WAS MINOR BRAIN SWELLING. THE PATIENT WAS ADMITTED TO HOSPITAL, THE HALO VEST WAS REMOVED, AND THE PATIENT TREATED WITH ANTICONVULSANTS AND ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425957 RESOLVE HALO TRACTION SYSTEM HAX OSSUR AMERICAS 515400D 05690977308657

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization