BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZNN CMN NAIL 13MMX44CM 130 L

    MDR report key: 3042108 · Received April 4, 2013

    Report

    Report Number
    9613350-2013-01476
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. A PRODUCT FAILURE CANNOT BE CONFIRMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED A ZNN CMN NAIL 13MMX44CM 130 L ON THE LEFT SIDE ON (B)(6) 2013 AND UNDERWENT REVISION SURGERY ON (B)(6) 2013 DUE TO BREAKAGE "WITH A FALL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138387 ZNN CMN NAIL 13MMX44CM 130 L ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDUL HSB ZIMMER GMBH 2581659

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R