BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA-LCP-2-COLUMN DRP2.4 VOLAR NARR LE SHA

    MDR report key: 2987052 · Received March 4, 2013

    Report

    Report Number
    8030965-2013-00710
    Event Type
    Malfunction
    Date Received
    March 4, 2013
    Date of Event
    January 21, 2013
    Report Date
    February 3, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K092556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS NOTED THAT THE THREAD OF THE VA-LCP 2-COLUMN DISTAL RADIUS PLATE IS DAMAGED. REPORTEDLY, THE FIRST AND SECOND LINE AT THE RADIUS SIDE OF THE PLATE, THE SCREW PENETRATED THE PLATE WITHOUT ANY RESISTANCE. THE DOCTOR DRILLED WITH FIXED ANGLE MODE WITHOUT USING THE GUIDING BLOCK. THE DOCTOR INSERTED THE SCREW WITH THE TORQUE LIMITER WITH DRIVER. DUE TO COLLES FRACTURE, THE PLATE WAS FIXED WITH THREE DISTAL SCREWS. THE SCREW WHICH PENETRATED THE PLATE WERE KEPT INDWELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90997 VA-LCP-2-COLUMN DRP2.4 VOLAR NARR LE SHA VA-LCP 2-COLUMN DISTAL RADIUS PLATE HRS SYNTHES GMBH 8042387

    Patients

    Seq Age Sex Outcome Treatment
    1