BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER SPINE PEDICLE FINDER

    MDR report key: 7442538 · Received April 19, 2018

    Report

    Report Number
    7442538
    Event Type
    Malfunction
    Date Received
    April 19, 2018
    Date of Event
    April 12, 2018
    Report Date
    April 13, 2018
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    MNI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE PREPARING THE RIGHT L4 THE PEDICLE FINDER TIP BROKE OFF. THE TIP WAS RETRIEVED USING A CLAMP FROM A SCREW REMOVAL SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287169 STRYKER SPINE PEDICLE FINDER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT MNI STRYKER ENDOSCOPY 09C290

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR NO