BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASS LP

    MDR report key: 10219624 · Received July 1, 2020

    Report

    Report Number
    1000432246-2020-00004
    Event Type
    Malfunction
    Date Received
    July 1, 2020
    Date of Event
    June 3, 2020
    Report Date
    July 1, 2020
    Manufacturer
    MEDICREA INTERNATIONAL
    Product Code
    KWP
    PMA / PMN Number
    K140738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    BOTH BROKEN UNID RODS IMPLANTED IN (B)(6) 2018. PATIENT IS UNSURE IF SHE WANTS A REVISION SURGERY BUT IS SYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680289 PASS LP UNID ROD KWP MEDICREA INTERNATIONAL B33226012-14 0UZ26F4M

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention