BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNESYS HA PEDICLE+SET SCREW 6.0X45

    MDR report key: 2516422 · Received March 29, 2012

    Report

    Report Number
    9613350-2012-00378
    Event Type
    Injury
    Date Received
    March 29, 2012
    Date of Event
    March 19, 2012
    Report Date
    March 21, 2012
    Manufacturer
    ZIMMER GMBH
    Product Code
    NQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. HOWEVER, THERE IS NO INDICATION FOR A PRODUCT FAILURE WHICH CAN BE RELATED TO THE SURGERY. SHOULD ADDITIONAL INFO BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES 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 DURING THE ORIGINAL SURGERY, THE FOLLOWING WAS IMPLANTED: 2QTY ARDIS CAGES (10X9X22), 2 QTY 6.0X40MM ZS TRANSITION SCREWS, 2 QTY 6.0X35MM OPTIMA PEDICLE SCREWS AT L5, 6.0X45MM DYNESYS HA SCREWS, UNIVERSAL SPACER 6-45, DTO IMPLANT 40MM AND 4 QTY 9X1.5MM STANDARD SET SCREWS. THE PT PRESENTED WITH LEFT SIDE PAIN. ADDITIONALLY XRAYS TAKEN ALSO LED SURGEON TO BELIEVE THERE WERE LOOSE SCREWS. UPON EXPOSURE AND INSPECTION, IT WAS FOUND THE DTO IMPLANT WAS NOT IN THE SCREW OR CAPTURED BY THE SET SCREW AT THE L4 ON LEFT SIDE OF PT. THE 40MM DTO IMPLANT, 9X1.5MM STANDARD SET SCREWS, DYNESYS HA SCREWS AND OPTIMA PEDICLE SCREW WERE REMOVED AT L5. THEY WERE REPLACED WITH 2QTY OPTIMA 7.0X45MM SCREWS AT L4, 6QTY 9X1.5MM SET SCREWS, 2QTY 6.0X80 CURVED RODS AND 1QTY ARDIS 12X11X30MM CAGE. POST-SURGERY, THE DYNESYS SCREW AND SET SCREW WERE INSPECTED AND IT WAS FOUND THE SET SCREW WAS VERY LOOSE, NOWHERE NEAR THE FINAL TORQUE INCH POUNDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYNESYS HA PEDICLE+SET SCREW 6.0X45 DYNESYS SPINAL SYSTEM WITH HA COATED SC NQP ZIMMER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R