BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASS LP

    MDR report key: 12150071 · Received July 12, 2021

    Report

    Report Number
    1000432246-2021-00003
    Event Type
    Malfunction
    Date Received
    July 12, 2021
    Date of Event
    June 14, 2017
    Report Date
    July 9, 2021
    Manufacturer
    MEDICREA INTERNATIONAL
    Product Code
    KWP
    PMA / PMN Number
    K140738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    FRACTURE OF T11 3MONTHS POST OP: PATIENT SUBTLY FELT SOME PAIN DURING KINESITHERAPY, OBSERVED ON XRAY. OSTEOPOROSIS TEST = POSITIF. (B)(6) 2017 : SURGERY T4S1 + PSO T12.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052952 PASS LP UNID ROD KWP MEDICREA INTERNATIONAL B33226012 DB62FC23 / 17D0711

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R