BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE, FIXATION, SPINAL INTERLAMINAL

    MDR report key: 6914455 · Received October 4, 2017

    Report

    Report Number
    1030489-2017-02147
    Event Type
    Injury
    Date Received
    October 4, 2017
    Report Date
    November 13, 2017
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    AS IT IS UNKNOWN AS TO WHICH DEVICE CONTRIBUTED TO THE EVENT WE ARE FILING THIS REPORT FOR NOTIFICATION PURPOSES: THE REPORTED DEVICES ARE GIVEN BELOW: PART ID/ LOT# / QTY / 510(K)# / UDI / PRODUCT CODE: 75446540 , UNK , 01 , K042025, (B)(4), KWP. 75446545 , UNK, 01 , K042025 , (B)(4), KWP. 2991122 , H11C0104 , 01 , K073291 , (B)(4), MAX . 7540020 , UNK, 01 , K052187 , (B)(4), KWP. UNKNOWN ROD , UNK , 01 , UNK , UNK , NKB. UNKNOWN BIOLOGIC , UNK , 01 , UNK , UNK , MQV. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT. ,

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2011 THE PATIENT UNDERWENT A SURGERY USING PEDICLE SCREWS, SPACER AND BIOLOGICS. POST-OP, THE PATIENT EXPERIENCED LEG AND ARM PAIN. THE PATIENT PRESENTED FOR A FOLLOW-UP ON AN UNKNOWN DATE IN 2012 FOR PAIN MANAGEMENT. THE PATIENT ALLEGEDLY COMPLAINED OF BACK PAIN RADIATING DOWN BACK AND ARMS, STIFFNESS IN BOTH HANDS, STOMACH PAINS, HEADACHES, SHARP PIN PAINS IN RIGHT LEG, STIFFNESS IN NECK, LOSS OF MOBILITY, AND SEVERE PAIN IN AREA WHERE THE IMPLANT WAS LOCATED AND SEXUAL ISSUES. THE DEVICES ARE NOT BROKEN AND REMAIN INTACT.

    Description of Event or Problem · 1

    PATIENT HAD SURGERY FOR L5-S1 FUSION. REPORTEDLY, POST-OP, INFECTION WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693669 APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other