BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDEAL COMPRESSION SCREW DIA. 4MM LG 45MM

    MDR report key: 840574 · Received April 19, 2007

    Report

    Report Number
    9615741-2007-00024
    Event Type
    Injury
    Date Received
    April 19, 2007
    Report Date
    April 19, 2007
    Manufacturer
    NEWDEAL S.A.
    Product Code
    HXX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REC'D. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE SALES REP REPORTED ON BEHALF OF THE USER FACILITY THE FOLLOWING INCIDENT: THE PHYSICIAN INSERTED THE SCREW USING A POWER DRILL. WHEN THE OUTSIDE SCREW HEAD LOCKED FLUSH WITH THE BONE, THE PHYSICIAN TRIED TO SCREW THE INNER SCREW HEAD AND MET RESISTANCE. THE INNER SCREW THREADS WOULD NOT ALIGN WITH THE OUTER SCREW THREADS. THE HEAD HAD DEFORMED. THE SCREW WAS EXTRACTED AND IS AVAILABLE FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IDEAL COMPRESSION SCREW DIA. 4MM LG 45MM I.CO.S.SYSTEM HXX NEWDEAL S.A. * E1JA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention