BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM CORTEX SCREW, SELF-TAPPING 58MM

    MDR report key: 2883766 · Received December 21, 2012

    Report

    Report Number
    8030965-2012-01653
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Report Date
    November 23, 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

    THIS DEVICE IS 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. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    RECEIVED DEVICE REPORT FROM SYNTHES (B)(4). A FACILITY IN (B)(6) REPORTED AN INCORRECT LABEL. WHEN OPENING THE PACKAGE TO PUT IN LOAN SET IT WAS NOTED THAT A SCREW WITH PART NUMBER 214.058 WAS IN THE PACKAGE. THE PACKAGE WAS LABELED WITH PART NUMBER 214.858.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5MM CORTEX SCREW, SELF-TAPPING 58MM 4.5MM CORTEX SCREW HWC SYNTHES GMBH 8012634

    Patients

    Seq Age Sex Outcome Treatment
    1