BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-STOP® INTERSPINOUS SPACER

    MDR report key: 3971233 · Received July 31, 2014

    Report

    Report Number
    1030489-2014-03378
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    November 26, 2013
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NQO
    PMA / PMN Number
    P040001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH IT IS UNKNOWN IF ANY MEDTRONIC DEVICES 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DECOMPRESSION PROCEDURE WAS PERFORMED ON A PATIENT AT L4/L5 USING AN INTERSPINOUS SPACER. THE PATIENT'S L5 SPINOUS PROCESS FRACTURED DURING THE DISTRACTION PHASE OF THE SURGERY, ACCORDING TO THE REPORT. IT WAS ALSO REPORTED THAT THE PHYSICIAN OPTED TO ABORT THE CASE DUE TO THE INCIDENT. THE INTERSPINOUS SPACER WAS NEVER IMPLANTED. NO FURTHER INFOMRATION IS KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446748 X-STOP® INTERSPINOUS SPACER PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Other