BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASS LP

    MDR report key: 7922600 · Received October 1, 2018

    Report

    Report Number
    1000432246-2018-00015
    Event Type
    Malfunction
    Date Received
    October 1, 2018
    Date of Event
    June 22, 2018
    Report Date
    October 2, 2018
    Manufacturer
    MEDICREA INTERNATIONAL
    Product Code
    MNI
    PMA / PMN Number
    K100297
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL SURGERY WAS PERFORMED ON (B)(6) 2016. TWO YEARS POST-OP PATIENT WAS BENDING FORWARD TO TIE HER SHOES WHEN SHE EXPERIENCED A "POP" ON THE LEFT SIDE OF HER LOW BACK. SHE IMMEDIATELY DEVELOPED SIGNIFICANT PAIN AFFECTING THE LEFT SIDE OF HER LOW BACK WHICH HAS PERSISTED SINCE THAT TIME. (B)(4). EXEMPTION E2017030.

    Description of Event or Problem · 0

    INITIAL SURGERY WAS PERFORMED ON (B)(6) 2016. TWO YEARS POST-OP PATIENT WAS BENDING FORWARD TO TIE HER SHOES WHEN SHE EXPERIENCED A "POP" ON THE LEFT SIDE OF HER LOW BACK. SHE IMMEDIATELY DEVELOPED SIGNIFICANT PAIN AFFECTING THE LEFT SIDE OF HER LOW BACK WHICH HAS PERSISTED SINCE THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765633 PASS LP UNID ROD MNI MEDICREA INTERNATIONAL EABE8E6E

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention