BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 5052653 · Received September 3, 2015

    Report

    Report Number
    1030489-2015-02194
    Event Type
    Injury
    Date Received
    September 3, 2015
    Date of Event
    August 4, 2015
    Report Date
    August 4, 2015
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THIS DEVICE IS NOT APPROVED FOR SALES IN USA BUT A SIMILAR DEVICE WITH CATALOG NUMBER 9393009 AND 510K NUMBER K094025 IS APPROVED FOR SALES IN USA. THE DEVICE WAS NOT RETURNED TO MANUFACTURER THEREFORE CAUSE OF EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    IMAGE REVIEW: FLUOROSCOPY TAKEN INTRA-OP. LEVELS IMPLANTED: L4-5.L4-5 PEEK GRAFT LOCATED IN RETROPERITONEAL SPACE. PLACEMENT IN THIS POSITION IS A RESULT OF OVER TAMPING AND IS A SURGICAL TECHNIQUE ISSUE. ROOT CAUSE: SURGICAL TECHNIQUE RELATED.

    Description of Event or Problem · 1

    PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE:DEGENERATIVE DISC DISEASE L4-L5 IT WAS REPORTED THAT INTRA-OP, DURING THE IMPLANT OF THE CAGE AT THE LEVEL L4-L5, THE SURGEON PUSHED THE CAGE TOO ANTERIORLY, OUT OF THE VERTEBRAL SPACE AS CONFIRMED BY THE X-RAY IMAGE. THE PATIENT DOES NOT HAVE ANY TROUBLES AT THE END OF THE SURGERY. THE SURGEON PLANS A 3D SCAN (MRI) AND TO RE-OPERATE THE PATIENT THROUGH AN ANTERIOR APPROACH. PATIENT COMPLICATIONS WERE REPORTED UNKNOWN. HOWEVER THE PATIENT WILL BE RE-OPERATED TO REMOVE THE CAGE FROM PATIENT'S ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584235 CRESCENT SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MSD DEGGENDORF MFG NA XS49

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention