BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTSCR 3.5 L36 TI

    MDR report key: 2944875 · Received February 5, 2013

    Report

    Report Number
    8030965-2013-00298
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 26, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    K112583
    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. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2012, TWO SCREWS BENT. IT IS REPORTED THAT THE SURGEON WAS ADJUSTING A MOLDED PLATE, AND WHILE DOING THIS, THE TWO SCREWS BENT. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47958 CORTSCR 3.5 L36 TI CORTEX SCREW HWC SYNTHES GMBH 8033138

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR