BEUDAMED
    FDA Adverse Event Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 2802818 · Received October 24, 2012

    Report

    Report Number
    1030489-2012-01959
    Date Received
    October 24, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 25, 2012
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    MAX
    PMA / PMN Number
    K094025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT CRACKED WHEN IMPLANTING INTO THE DISC SPACE. TWO SMALL PIECES OF THE IMPLANT WERE REMOVED. THE DISC SPACE WAS INSPECTED AND PART OF THE IMPLANT REMAINED IN THE PT. THERE WAS NO HARM TO THE PATIENT'S DISC SPACE THEREFORE, THE REMAINING IMPLANT WAS OK. PART OF THE IMPLANT WAS LEFT IN THE DISC SPACE. TYPE OF PROCEDURE: TLIF LUMBAR FUSION LEVELS IMPLANTED: 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRESCENT SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MDT SOFAMOR DANEK PUERTO RICO MFG NA H11B6424

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Other