BEUDAMED
    FDA Adverse Event Other Summary report: N

    DYNESYS HA PEDICLE+SET SCREW 6.0X40

    MDR report key: 3772270 · Received March 25, 2014

    Report

    Report Number
    9613350-2014-03397
    Event Type
    Other
    Date Received
    March 25, 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
    PHYSICIAN

    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 AMENDE MEDICAL DEVICE REPORT WILL BE SUBMITTED. ANOTHER REPORT IS SUBMITTED FOR THIS COMPLAINT AS 2 DYNESYS HA 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 RECEIVED A DYNESYS HA PEDICLE+SET SCREW 6.4X50 ON (B)(6) 2012. CURRENTLY THE PATIENT IS BEING MONITORED. THE FOLLOWING WAS REPORTED. "CORE LAB ANALYSIS OF 12 MONTH POST-OP FILMS SHOWS SUPERIOR L3 COMPRESSION FRACTURE". NO ASSOCIATED ADVERSE EVENT OR SERIOUS ADVERSE EVENT HAS BEEN REPORTED BY THE SITE". "PRIMARY INDICATION FOR INDEX PROCEDURE: SPONDY SECONDARY INDICATION: STENOSIS MEDICAL HX: DIABETES". IT WAS ALSO STATED UNDER THE SUPPORTING DOCUMENTS THAT "THE FRACTURES WERE IDENTIFIED VIA AN OUTSIDE REVIEW OF FILMS AS PART OF THE (B)(4)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175301 DYNESYS HA PEDICLE+SET SCREW 6.0X40 DYNESYS SPINAL SYSTEM WITH HA COATED S NQP ZIMMER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other