BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

    MDR report key: 2485075 · Received March 9, 2012

    Report

    Report Number
    2953769-2012-00025
    Event Type
    Injury
    Date Received
    March 9, 2012
    Date of Event
    February 8, 2012
    Report Date
    February 8, 2012
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    NQO
    PMA / PMN Number
    P040001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): (NO CODE AVAILABLE FOR "SPINOUS PROCESS CRACK"). 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

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH STENOSIS UNDERWENT A SPINAL PROCEDURE USING AN INTERSPINOUS SPACER DEVICE. AFTER THE PHYSICIAN MEASURED L4/5, A CRACK WAS NOTICED ON THE L5 SPINOUS PROCESS AS THE TRIAL SPACER WAS BEING PLACED. THE PHYSICIAN CHANGED THE PROCEDURE TO A LAMINECTOMY. THE PHYSICIAN STATED THAT THE SIZING DISTRACTOR MAY HAVE BEEN EXTENDED TOO MUCH. NO OTHER COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS REPORTED AS "GOOD". IT WAS ALSO REPORTED THAT THE PATIENT DID NOT HAVE OSTEOPOROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO MEDTRONIC SPINE LLC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Required Intervention