BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNESYS HA PEDICLE+SET SCREW 6.4X50

    MDR report key: 1253349 · Received December 1, 2008

    Report

    Report Number
    9613350-2008-00244
    Event Type
    Injury
    Date Received
    December 1, 2008
    Date of Event
    October 29, 2008
    Report Date
    October 31, 2008
    Manufacturer
    ZIMMER GMBH
    Product Code
    NQP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A CHECK OF THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS OF THE SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW WAS FOUND TO BE VERY LOOSE AT L3 LEFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYNESYS HA PEDICLE+SET SCREW 6.4X50 DYNESYS SPINAL SYSTEM WITH HA COATED SCREWS NQP ZIMMER GMBH 2405588

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R