BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIBLOCK FRACTURE PLANTING SYSTEM

    MDR report key: 7432185 · Received April 13, 2018

    Report

    Report Number
    MW5076485
    Event Type
    Malfunction
    Date Received
    April 13, 2018
    Report Date
    April 13, 2018
    Manufacturer
    ACUTE INNOVATIONS LLC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD THE FIRST RIBLOCK IMPLANTED IN (B)(6) 2016 AND HAS HAD THREE SURGERIES TO REPLACE BROKEN RIBLOCK DEVICES. A TOTAL OF FOUR OF THESE DEVICES HAVE GOTTEN BROKEN IN HER. AS A RESULT OF DEVICE BREAKAGE, PATIENT HAS SUFFERED A PUNCTURED LUNG, 4 FRACTURED RIBS, SHORTNESS OF BREATH, PNEUMONIA, INFECTION, DISCOMFORT AND HAS LOST HER JOB AND PROFESSION AS A HORSE TRAINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274259 RIBLOCK FRACTURE PLANTING SYSTEM RIBLOCK FRACTURE PLANTING SYSTEM HWC ACUTE INNOVATIONS LLC
    274260 RIBLOCK FRACTURE PLANTING SYSTEM RIBLOCK FRACTURE PLANTING SYSTEM HWC ACUTE INNOVATIONS LLC
    274261 RIBLOCK FRACTURE PLANTING SYSTEM RIBLOCK FRACTURE PLANTING SYSTEM HWC ACUTE INNOVATIONS LLC
    274262 RIBLOCK FRACTURE PLANTING SYSTEM RIBLOCK FRACTURE PLANTING SYSTEM HWC ACUTE INNOVATIONS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1