BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNESYS HA PEDICLE+SET SCREW 6.4 X 55

    MDR report key: 1030858 · Received April 9, 2008

    Report

    Report Number
    9613350-2008-00018
    Event Type
    Injury
    Date Received
    April 9, 2008
    Date of Event
    February 28, 2008
    Report Date
    March 3, 2008
    Manufacturer
    ZIMMER GMBH
    Product Code
    NQP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE. A CHECK OF THE MFG PAPERS OF ALL MENTIONED PARTS DID NOT SHOW ANY DEVIATIONS TO THEIR SPECS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT EXPERIENCING PAIN AND L3 LEFT SIDE SCREW DISCOVERED BROKEN DURING 2008 OFFICE VISIT. REP REPORTED NINETEEN DAYS LATER OF A BROKEN PEDICLE SCREW AT L3 RIGHT SIDE. ORIGINAL SURGERY DATE OF 2007. POST LATERAL FUSION; NO INTERBODY FUSION. REVISION SURGERY OCCURRED IN 2008 TO REMOVE THE SCREW AND REPLACED WITH 8.0X55MM. ALSO IDENTIFIED THAT L3 LEFT SCREW WAS LOOSE. THIS SCREW WAS REMOVED AND REPLACED WITH 8.0 X 55MM. CONSTRUCT EXTENDED TO L2 DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYNESYS HA PEDICLE+SET SCREW 6.4 X 55 DYNESYS SPINAL SYSTEM WITH HA COATED SYSTEM NQP ZIMMER GMBH NA 2271342

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R