BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C

    MDR report key: 3101711 · Received May 9, 2013

    Report

    Report Number
    8030965-2013-02146
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    March 22, 2013
    Report Date
    April 12, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    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. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A CRANIOTOMY CLIPPING ON (B)(6) 2013, A SCREW BROKE AT THE HEAD. THE HEAD OF ONE SCREW WAS BROKEN DURING THE INSERTION INTO THE SKULL. THE SCREW WAS INSERTED VERTICALLY WITHOUT ANY EXCESSIVE FORCE. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203980 MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C HWC SYNTHES GMBH 7940162

    Patients

    Seq Age Sex Outcome Treatment
    1