BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIGER

    MDR report key: 4961363 · Received July 30, 2015

    Report

    Report Number
    1935627-2015-00008
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    June 19, 2015
    Report Date
    July 29, 2015
    Manufacturer
    CORELINK, LLC
    Product Code
    MNH
    PMA / PMN Number
    K110321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DHR COULD NOT BE REVIEWED AS NO PART#S AND/OR LOT#S WERE GIVEN. THE PHYSICIAN IDENTIFIED THAT THEY WERE NOT PLANNING ON DOING A REVISION SURGERY TO CORRECT THIS ISSUE.

    Description of Event or Problem · 1

    SURGERY DATE IS UNKNOWN. THE DISTRIBUTOR IDENTIFIED TO THE MANUFACTURER THAT THE ROD CONSTRUCT HAD COME LOOSE IN THE ILIAC REGION. THE PRODUCTS WERE ORIGINALLY UTILIZED FOR A REVISION SURGERY. THE PHYSICIAN SPOKE WITH AN ENGINEER DUE TO THE BELIEF THAT SHE THOUGH SHE UTILIZED RODS THAT WERE TOO SMALL. THE PHYSICIAN WAS NOT PLANNING ON DOING A CORRECTIVE SURGERY AT THIS TIME. NO PART#S OR LOT#S WERE IDENTIFIED TO US FOR REVIEW OF THE DHR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498365 TIGER PEDICLE SCREW SYSTEM MNH CORELINK, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other