BEUDAMED
    FDA Adverse Event Other Summary report: N

    DTL CANN. PEDICLE+SET SCREW 6.4X50

    MDR report key: 3772237 · Received March 26, 2014

    Report

    Report Number
    9613350-2014-03399
    Event Type
    Other
    Date Received
    March 26, 2014
    Date of Event
    February 28, 2014
    Report Date
    February 28, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    NQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES FOR REVIEW, AS THE PATIENT IS CURRENTLY BEING MONITORED AND HAS NOT BEEN REVISED TO DATE. THREE X-RAYS AND OTHER SOURCE DOCUMENTS (DYNESIS CATALOGUE NUMBERS, PATIENT INFO REVIEW, DYNESIS RESULT OVERVIEW) WERE RECEIVED. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ANOTHER REPORT IS SUBMITTED FOR THIS COMPLAINT AS 2 DTL CANN. PEDICLE+SET SCREW 6.4X50 WERE INVOLVED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A DTL CANN. PEDICLE+SET SCREW 6.4X50 ON (B)(6) 2013. CURRENTLY, THE PATIENT IS BEING MONITORED. IT WAS STATED: "(B)(4) STUDY CORE LAB ANALYSIS OF 6 MONTH POST UP FILMS REVEALS "MILD SUPERIOR COMPRESSION FRACTURE OF L2". NO ASSOCIATED ADVERSE EVENT OR SERIOUS ADVERSE EVENT HAS BEEN REPORTED FOR THIS EVENT." "INDICATION FOR INDEX SURGERY: GRADE 1 SPONDY AND STENOSIS, L2-L3, L3-L4; MEDICAL HX: DIABETES, HYPERTENSION, HIGH CHOLESTEROL, PRIOR DECOMPRESSION/LAMINECTOMY IN 199". IT WAS ALSO STATED UNDER THE SUPPORTING DOCUMENTS THAT THE FRACTURE WAS IDENTIFIED VIA AN OUTSIDE REVIEW OF FILMS AS PART OF THE (B)(4)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178223 DTL CANN. PEDICLE+SET SCREW 6.4X50 DYNESYS TOP-LOADING SPINAL SYSTEM NQP ZIMMER GMBH 01.03916.450 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other