BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNESYS PEDICLE+SET SCREW 6.0X40

    MDR report key: 3001544 · Received March 11, 2013

    Report

    Report Number
    9613350-2013-01412
    Event Type
    Injury
    Date Received
    March 11, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    NQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE THE EXPLANTED DEVICES FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE CAUSE OF THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. HOWEVER THERE IS NO INDICATION FOR A PRODUCT FAILURE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND /OR THE DEVICES BE RETURNED FOR EVALUATION AND INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR CORRECTIVE MEASURE IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED A DYNESYS PEDICLE+SET SCREW 6.0X40 ON (B)(6) 2013 DUE TO INCREASED PAIN, LOOSE AND BROKEN SCREWS. FURTHER THE FOLLOWING WAS REPORTED: "X-RAY SHOWED THE SCREW AT THE RIGHT L4 WAS BROKEN AND THE REST OF THE SCREWS WERE LOOSE. LEFT L5 PN (B)(4) AND L4 SCREWS WERE LOOSE. RIGHT AND LEFT L3 SCREWS WERE COMPLETELY LOOSE. THE RIGHT L5 PN (B)(4) WAS NOT LOOSE. THE DTO CORD WAS REMOVED AFTER CUTTING THE SPACERS IN ONE PIECE. BECAUSE OF THE TOTAL LOOSENING OF THE DYNESYS SCREWS. THE CONSTRUCT WAS REMOVED WITHOUT ANY IMPLANT REPLACEMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102101 DYNESYS PEDICLE+SET SCREW 6.0X40 DYNESYS PEDICLE+SET SCREW 6.0X40 NQP ZIMMER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other