BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE, FIXATION, SPINAL INTERLAMINAL

    MDR report key: 9709988 · Received February 13, 2020

    Report

    Report Number
    1030489-2020-00172
    Event Type
    Injury
    Date Received
    February 13, 2020
    Report Date
    April 15, 2020
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER: OUTCOMES TO ADVERSE EVENT: PAIN IT IS UNKNOWN WHETHER THIS PRODUCT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT OR NOT. WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 THE PATIENT UNDERWENT OPEN SURGERY AT T11-T12, T12-L1, L1-L2,L2-L3, L3-L4, L4-L5, L5-S1 DUE TO DEFORMITY. POST-OP, PATIENT SUFFERING FROM PAIN AND TINGLING SENSATION IN DIGIT 3 LEFT FOOT WITH BACK PAIN AND RADIATING PAIN BILATERAL ANTEROLATERAL UPPER LEGS (NO ISCHIALGY) AFTER HEARING A CRACK WHILE STANDING UP. ACTION TAKEN: PAIN MEDICATION GIVEN, DRY ASEPTIC WOUND CARE.

    Description of Event or Problem · 1

    THE CRACK IS A SYMPTOMS OF A PROXIMAL JUNCTIONAL KYPHOSIS. THIS PJK IS CAUSED BY THE URGE OF THE PATIENT TO LEAN MORE FORWARD DURING THE RECOVERY PROCESS OF THE LORDNESS POSITION DURING THE OPERATION. RELATIONSHIP TO THE PROCEDURE- THE CRACK IN HER BACK IS A SYMPTOM RELATED TO PJK WHICH IS RELATED TO THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172703 APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other