BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZURICH MAXDRIVE SCREW

    MDR report key: 4093564 · Received September 3, 2014

    Report

    Report Number
    9610905-2014-00020
    Event Type
    Injury
    Date Received
    September 3, 2014
    Date of Event
    August 13, 2014
    Report Date
    September 2, 2014
    Manufacturer
    KARL LEIBINGER MEDIZINTECHNIK GMBH U. CO. KG
    Product Code
    MQN
    PMA / PMN Number
    K010139
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR EVAL. SURGEON USED A NON-KLS MARTIN L.P. SCREWDRIVER IN CONJUNCTION WITH THE KLS MARTIN L.P. SCREW. SURGEON WAS ADVISED THAT THE SCREW COULD BREAK IF USING A NON-KLS MARTIN L.P. SCREWDRIVER; HOWEVER, THE SURGEON PROCEEDED. IF FURTHER INFO IS ACQUIRED THAT ADDS VALUE TO THE CONTENT OF THIS REPORT AND/OR A VALID CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    DURING SURGERY, SCREW HEAD BROKE OFF WHILE IMPLANTING IN PATIENT'S BONE. SCREW SHAFT STILL REMAINS IN THE BONE. NO ADDITIONAL SURGERY REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537266 ZURICH MAXDRIVE SCREW MQN KARL LEIBINGER MEDIZINTECHNIK GMBH U. CO. KG 50-348-09-09 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other