BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WASHER 13.0MM

    MDR report key: 2872012 · Received December 13, 2012

    Report

    Report Number
    8030965-2012-01568
    Event Type
    Injury
    Date Received
    December 13, 2012
    Report Date
    November 14, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTN
    PMA / PMN Number
    PREAMEND
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH SCREW AND WASHER IN THE PELVIS ON UNKNOWN DATE. PATIENT REPORTED PAIN. PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2012 FOR REMOVAL OF HARDWARE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WASHER 13.0MM WASHER HTN SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention SCREW