BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DHS/DCS COMPRESSION SCREW, 36MM

    MDR report key: 2841302 · Received November 1, 2012

    Report

    Report Number
    2520274-2012-02825
    Event Type
    Injury
    Date Received
    November 1, 2012
    Date of Event
    September 14, 2012
    Report Date
    October 4, 2012
    Product Code
    HWC
    PMA / PMN Number
    K791619
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER: DETERMINED DURING THE EVALUATION PROCESS THIS SCREW WAS RECEIVED WHOLE AND INTACT. THIS SCREW APPEARS TO BE A COMPRESSION SCREW. IF SO, THE HEAD GEOMETRY, M4 THREAD, AND 36MM LENGTH WOULD MAKE THIS A 280.990. THE HEX DRIVE HAS LIGHT MARKINGS, CONSISTENT WITH NORMAL USE. THE HEAD IS IN GOOD CONDITION WITH ONLY LIGHT MARKS AT THE BAND AND AT THE TRANSITION. THE THREADS APPEAR TO BE IN VERY GOOD CONDITION WITH NO MARKS NOR DAMAGE NOTED. THE THREAD RUNOUT AT THE TIP SHOWS SOME MINOR GALLING. ALL OF THE PERTINENT DIMENSIONS THAT WERE CHECKED ARE WITHIN SPECIFICATIONS. A REVIEW OF THE DESIGN, COMPLAINT HISTORY AND RISK ANALYSIS INDICATES THAT THE DESIGN IS ADEQUATE FOR ITS INTENDED USE. BONY UNION IS DEPENDENT ON A MULTITUDE OF FACTORS, SUCH AS PROPER REDUCTION, BONE QUALITY, PATIENT COMPLIANCE, IMPLANT SELECTION, ETC. THE LACK OF ADDITIONAL INFORMATION PREVENTS A COMPLETE ANALYSIS OF THE CAUSE OF FAILURE. ADDITIONALLY, THE PATIENTS FALL MAY HAVE CAUSED A RE-FRACTURE. THIS DEVICE WAS USED FOR TREATMENT.

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    (B)(4) RECEIVED, A COPY WILL BE INCLUDED WITH THE REPORT. THIS IS 3 OF 7 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DHS/DCS COMPRESSION SCREW, 36MM DHS/DCS COMPRESSION SCREW, 36MM HWC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LAG SCREW| SCREWS| PLATE