BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE, FIXATION, SPINAL INTERLAMINAL

    MDR report key: 5740878 · Received June 22, 2016

    Report

    Report Number
    1030489-2016-01854
    Event Type
    Injury
    Date Received
    June 22, 2016
    Report Date
    May 27, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS WERE IMPLANTED IN (B)(6) 2011. THE EXACT IMPLANT DATE IS UNKNOWN. THE PRODUCTS WERE IMPLANTED IN (B)(6) 2011. THE EXACT IMPLANT DATE IS UNKNOWN. (B)(4). DEVICES OF MULTIPLE PART/LOT NUMBERS WERE IMPLANTED DURING THE PROCEDURE INCLUDING: PART: 9790313 / LOT: UNK (X1) PART: 6958714 / LOT: UNK (X1) PART: 6958924 / LOT: UNK (X1) PART: 6950315 / LOT: UNK (X1) THE MANUFACTURER COULD NOT DETERMINE THE SUSPECTED PRODUCTS. WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, SCREWS CAME LOOSE AND PATIENT UNDERWENT A REMOVAL SURGERY IN (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396246 APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention