BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSTONE CONTROL SPINAL SYSTEM

    MDR report key: 5381936 · Received January 20, 2016

    Report

    Report Number
    1030489-2016-00208
    Event Type
    Injury
    Date Received
    January 20, 2016
    Date of Event
    December 27, 2015
    Report Date
    December 27, 2015
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    PMA / PMN Number
    K120368
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WITH MULTIPLE LOT NUMBERS WERE IMPLANTED INCLUDING: PRODUCT ID: LOT NO. QUANTITY 4001022 ZK99 ; 1 4001022 ZS55 1 IT IS UNKNOWN AT THIS MOMENT WHICH CAGE WAS FOUND TO BE DISLOCATED. (B)(6). (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE CAUSE OF EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION SURGERY FOR L4 DEGENERATIVE SPONDYLOLISTHESIS AT L4-L5 ON (B)(6) 2015. POST-OP, SPONDYLOLISTHESIS WAS OBSERVED AGAIN DUE TO LOOSENING OF 2 SCREWS AT L4 AND CAGE DISLOCATION. THE PATIENT COMPLAINED OF NEUROLOGICAL SYMPTOM AND BACK PAIN. REVISION SURGERY WAS PERFORMED TO ADD SCREW AT L3 AND REPLACED WITH BIGGER SCREWS AT L4. THE SURGEON REMOVED TWO CAGES AND PERFORMED POSTERIOR LUMBAR INTERBODY FUSION SURGERY AGAIN ON (B)(6) 2015. THE REVISION SURGERY TOOK TIME AROUND 4 HOURS INCLUDING REPLACEMENT OF CAGE.THE SURGEON COMMENTED THAT SCREW WAS UNSTABLE DUE TO BONE BEING WEAK AND FIXATION OF CAGE AT FIRST WAS BAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40110 CAPSTONE CONTROL SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MSD DEGGENDORF MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R