BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSTONE SPINAL SYSTEM

    MDR report key: 2852767 · Received November 30, 2012

    Report

    Report Number
    1030489-2012-02508
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    MAX
    PMA / PMN Number
    K073291
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: MEDICAL INTERPRETATION: CT SCANS PROVIDED OF L3-L5 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). ONE AXIAL AND TWO SAGITTAL VIEWS OF L3-L4-L5 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). SPACER AT L4/5 IS METALLIC AND NOT DEVICE. SPACER AT L3-4 IS A DIFFERENT DEVICE AND COULD BE THE 1ST SPACER. PEDICLE SCREWS IN PLACE L3-L4-L5 WITH DIGITAL SUBTRACTION TECHNIQUES TO MANAGE ARTIFACT. AXIAL VIEW IS THROUGH UPPER L3 SCREWS SHOWING BONE LOSS AROUND SCREWS INDICATING POSSIBLE LOOSENING. NO SOLID FUSION NOTED AT L3-4. CYST IS DEVELOPING INTO BODY OF L3 BASED FROM AREA OF SPACER. NORMAL REMODELING NOTED AT L4/5. CONSISTENT WITH CHRONIC NON UNION WITH INSTABILITY OR INFECTION.

    Description of Event or Problem · 1

    IT WAS OBSERVED THAT "EROSION" OF BOTH CRANIAL AND CAUDAL ENDPLATES OF THE TREATED DISK. BONE UNION HAS NOT OCCURRED. THE PATIENT WILL UNDERGO A REVISION SURGERY VERY SOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSTONE SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS NA H11B7832

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Required Intervention