BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

    MDR report key: 2490398 · Received March 13, 2012

    Report

    Report Number
    2953769-2012-00030
    Event Type
    Injury
    Date Received
    March 13, 2012
    Report Date
    December 5, 2011
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    NQO
    PMA / PMN Number
    P040001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THE EVENT IS UNKNOWN. (B)(4) (INFECTION), (B)(4) (NO KNOWN DEVICE PROBLEM). ALTHOUGH IT IS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. 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 IN AN ARTICLE THAT A REVIEW OF 512 PATIENTS WHO UNDERWENT INTERSPINOUS SPACER IMPLANTATIONS BETWEEN 2006 AND 2010 AT AN INSTITUTION WAS CONDUCTED. THE INTERSPINOUS SPACER DEVICE WAS USED IN PATIENTS WITHOUT SYNOVIAL CYSTS, WITH SYNOVIAL CYSTS, AND CYSTS 3MM. DATA WAS INCLUDED ONLY FOR 285 PATIENTS WITH AT LEAST 6 MONTHS OF CLINICAL FOLLOW-UP. AS COMPLICATIONS, IT WAS REPORTED ONE PATIENT EXPERIENCED A WOUND INFECTION. NO FURTHER PATIENT INFORMATION WAS REPORTED.

    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 Other