BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SNP UNICORTICAL SCREW

    MDR report key: 1002238 · Received February 20, 2008

    Report

    Report Number
    1818910-2008-00698
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    January 20, 2008
    Report Date
    January 21, 2008
    Manufacturer
    DEPUY ACE S.A. 'R.L.
    Product Code
    LXT
    PMA / PMN Number
    K060290
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE HEAD OF THE SCREW BROKE OFF. THE BODY OF THE SCREW WAS LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SNP UNICORTICAL SCREW 87LXT LXT DEPUY ACE S.A. 'R.L. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR