BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASS LP

    MDR report key: 8206344 · Received December 31, 2018

    Report

    Report Number
    1000432246-2018-00017
    Event Type
    Malfunction
    Date Received
    December 31, 2018
    Date of Event
    November 5, 2018
    Report Date
    December 27, 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

    ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2016, WITH BOTH RODS BEING BENT IN-SITU. BOTH RODS EVENTUALLY BROKE AND WERE DETECTED ON THE 23 MONTH POST-OP X-RAYS. THE PATIENT HAD REVISION SURGERY ON (B)(6) 2018. (B)(4). EXEMPTION E2017030.

    Description of Event or Problem · 0

    ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2016, WITH BOTH RODS BEING BENT IN-SITU. BOTH RODS EVENTUALLY BROKE AND WERE DETECTED ON THE 23 MONTH POST-OP X-RAYS. THE PATIENT HAD REVISION SURGERY ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045053 PASS LP UNID ROD MNI MEDICREA INTERNATIONAL 838D90AL

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention