BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLOVERLEAF FUSION PL 2.4/2.7 VA LOCK 2HO

    MDR report key: 3173009 · Received June 17, 2013

    Report

    Report Number
    2520274-2013-03445
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K100776
    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. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: WHILE BENDING THE PLATE DURING THE PROCEDURE ON (B)(6) 2013, A SMALL METAL SPLINTER FORMED. THE PLATE WAS NOT INSERTED. 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
    273057 CLOVERLEAF FUSION PL 2.4/2.7 VA LOCK 2HO HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR