BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASS LP

    MDR report key: 12281450 · Received August 5, 2021

    Report

    Report Number
    1000432246-2021-00006
    Event Type
    Malfunction
    Date Received
    August 5, 2021
    Date of Event
    June 4, 2014
    Report Date
    August 5, 2021
    Manufacturer
    MEDICREA INTERNATIONAL
    Product Code
    NKB
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    (B)(6) CLINICAL INVESTIGATION EVENT. A BROKEN HOOK WAS DETECTED DURING A 12-MONTH POST-OP CONTROL. NO SURGICAL REVISION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182710 PASS LP HOOK NKB MEDICREA INTERNATIONAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other